DEPARTMENT OF HEALTH AND SOCIAL SERVICES

Division of Public Health

PROPOSED

PUBLIC NOTICE

4465 Delaware Radiation Control Regulations

On June 1, 2017, the Department of Health and Social Services, Division of Public Health, Office of Radiation Control, plans to publish revised Regulations Governing Radiation Control - Part F and Part H and hold them out for public comment per Delaware law.

NOTICE OF PUBLIC HEARING

A public hearing will be held on Friday, June 23, 2017, at 10:00 a.m. in the First Floor Conference Room, located in the Jesse Cooper Building, 417 Federal Street, Dover, Delaware.

The Authority on Radiation Protection (ARP), with the Office of Radiation Control, Health Systems Protection Section, Division of Public Health, Department of Health and Social Services, is proposing to repeal and replace two chapters of Delaware Radiation Control Regulations. The purpose of the amendments is to update the requirements so that they are in concert with current healthcare and industry standards, and to align them more closely with current state administrative code and federal requirements. The regulations will apply to any facility or person that receives, possesses, uses, transfers, sells, owns or acquires ionizing radiation sources, or provides radiation services to such radiation source facilities, or who administers machine-generated radiation to human patients in the healing arts.

Any person who wishes to make written suggestions, testimony, briefs or other written materials concerning the proposed regulation should submit such comments by Friday, July 14, 2017 to:

Jamie Mack, Executive Assistant

Office of the Director

Delaware Division of Public Health

Jesse Cooper Building

417 Federal St.

Dover, DE 19901

Email: jamie.mack@state.de.us

Fax: 302-739-3984

4465 Delaware Radiation Control Regulations

Part A General Provisions

Except as otherwise specifically provided, these regulations apply to all persons who receive, possess, use, transfer, own, or acquire any source of ionizing radiation. However, nothing in these regulations except for registration of radiation machine facilities/sources as specified in Regulation 4465 Part B shall apply to any person to the extent such person is subject to regulation by the Nuclear Regulatory Commission. See 4465 Parts C & G of these regulations which pertain to radioactive materials licensing and federal oversight.

As used in these regulations, these terms have the definitions set forth below. Additional definitions used only in a certain Part will be found in that Part.

"A1" means the maximum activity of special form radioactive material permitted in a Type A package. "A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.

"Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

"Accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

"Accelerator-produced material" means any material made radioactive by a particle accelerator.

"Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

“Address of use” means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.

"Adult" means an individual 18 or more years of age.

“Agency” means the Division of Public Health, Delaware Department of Health and Social Services.

"Agreement State" means any State with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

"Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

"Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DAC's) specified in Appendix B, Table I of Part D of these regulations; or

(2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours.

"Airline respirator" (see"Supplied-air respirator (SAR)").

"Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

“As low as is reasonably achievable" (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

"Assigned Protection Factor (APF)" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

"Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.

“Authorized user” means a practitioner of the healing arts who is identified as an authorized user on an Agency, Agreement State, Licensing State or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.

"Background radiation" means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Agency.

"Becquerel" (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).

"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term.

"Brachytherapy" means a method of radiation therapy in which radiation sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.

"Byproduct material" means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

(2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

(3) (i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

"Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

"Calibration" means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.

"CFR" means Code of Federal Regulations.

“Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per Title 24 Delaware Code, Chapter 7, Board of Chiropractic, as amended.

"Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

"Committed dose equivalent" (HT.50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

"Committed effective dose equivalent" (HE.50) is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = Σ wT HT,50).

“Controlled area” means an area, outside of a restricted but inside the site boundary, access to which can be limited by the licensee or registrant, for any reason.

“Critical group” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

"Curie" means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

"Deep dose equivalent" (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).

"Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation

“Dentist” shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code, Chapter 11, Dentistry and Dental Hygiene, as amended.

"Department of Energy" means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and re-transferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)

"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

“Discrete Source” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

"Dose equivalent (HT)" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

"Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.

"Effective dose equivalent (HE)" means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).

"Embryo/fetus" means the developing human organism from conception until the time of birth.

"Exposure" generally means being exposed to ionizing radiation or to radioactive material;

"Exposure Units" specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Section A.9.1 of this Part for Units of Exposure and Dose.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

"Extremity" means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.

“Facility” means the location, building vehicle, or complex under one administrative control, at which one or more radiation sources are installed, located and/or used.

"Filtering facepiece (dust mask)" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

"Fit Test" means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.

"Former Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory Commission licenses have been terminated.

"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

"Gray" (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.

“Healing arts” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.

“Healing arts screening” means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.

"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.

"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

"Human use" means the internal or external administration of radiation or radioactive material to human beings.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or

(2) Committed effective dose equivalent (a) by bioassay or (b) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. [See the definition of DAC-hours in 4465 Part D of these regulations.]

(3) Dose equivalent by the use of survey data.

"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.

"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.

"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.

"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

"JRCECT" means Joint Review Committee on Education in Cardiovascular Technology

“JRCNMT” means Joint Review Committee on Nuclear Medicine Technology

"JRCERT" means Joint Review Committee on Education in Radiologic Technology

"Lens dose equivalent (LDE)" means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

"License" means a license issued by the US Nuclear Regulatory Commission, Agreement State, or the Agency, in accordance with applicable federal or state regulations, as amended.

“Licensed Practitioner” means a physician licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state.

"Licensed Practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, advanced practice nursing, or veterinary medicine in this state.

"Licensed [or registered] material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.

"Licensee" means the holder of a license.

"Limits" [See "Dose limits"].

"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lost or missing source of radiation" means licensed [or registered] source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in T.2 of these regulations.

"Member of the public" means any individual except when that individual is receiving an occupational dose.

"Minor" means an individual less than 18 years of age.

“Misadministration” means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, Section 5.2 of these regulations.

"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"Negative pressure respirator (tight fitting)" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

"NORM" means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.

"NRC" means the US Nuclear Regulatory Commission or its duly authorized representatives.

“Notice of Violation” means a written statement of one or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:

(1) Corrective steps taken by the licensee, registrant or other permit holder and the results achieved;

(2) Corrective steps to be taken to prevent recurrence; and

(3) The projected date for achieving full compliance. The Authority may require responses to notices of violation to be under oath.

"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.

“Office of Engineering” means the office in the Delaware Division of Public Health that reviews radiation shielding plans and/or design plans and issues an Approval to Construct letter for new radiation source facilities or rooms.

“Office of Radiation Control” means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.

“Owner/Leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager to sign the application form.

"Package" means the packaging together with its radioactive contents as presented for transport.

"Particle accelerator" [See "Accelerator"].

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other State or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].

"Personnel monitoring equipment" [See "Individual monitoring devices"].

"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.

“Podiatrist” means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.

"Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

"Powered air-purifying respirator (PAPR)" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

“Principal Supervisor” means the State-Licensed Practitioner responsible for initiating use of x-ray equipment or other device generating ionizing radiation in the healing arts.

"Protective apron" means an apron made of radiation-attenuating materials used to reduce exposure to radiation.

"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.

“Qualified expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations, as amended.

“Qualified Medical Physicist” means an individual qualified in accordance with Regulation 4465, Part X, Therapeutic Radiation Machines, Section 3.4, as amended. means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Part X, subsection 3.4, as amended.

"Qualitative fit test (QLFT)" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.

"Quality factor" (Q) means the modifying factor, listed in Tables I and II of A.13, that is used to derive dose equivalent from absorbed dose.

"Quantitative fit test (QNFT)" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

"Rad" means the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

"Radiation" means alpha particles, beta particles, gamma rays, x rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" [See "Dose"].

"Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

“Radiation Safety Officer” or RSO for a radiation machine facility means an individual assigned to perform RSO duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.

"Radiation Technician" means any individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.

"Radiation Technologist" means any individual who has successfully completed a JRCERT/JRCCVT approved program in radiation technology and has passed a national certification examination in his/her field of specialization.

"Radiation Technology" means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.

"Radioactive material" means any solid, liquid or gas which emits radiation spontaneously.

"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" [See "Bioassay"].

"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to these regulations and the Act.

"Registration" means registration with the Agency in accordance with the regulations adopted by the Agency.

"Regulations of the Department of Transportation" means the regulations in 49 CFR Parts 100-189, as amended.

"Rem" means the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)

"Research and development" means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings in the healing arts.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee’s control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of these regulations.

"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

"Roentgen" means the traditional unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and Part A.9.1 of this part.)

“State Radiation Control Act” or “the Act” means Title 16 Delaware Code, Chapter 74, Radiation Control, as amended.

"Sealed source" means any encapsulated radioactive material, which has been constructed in such a manner as to prevent the escape of any radioactive material.

"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC), that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.

"Self-contained breathing apparatus (SCBA)" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

"Shallow dose equivalent" (Hs), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.

"SI" means the abbreviation for Standard Internationale, the International Metric System of Measurement.

"Sievert" means the Standard Internationale (SI) unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)

"Source material" means:

(1) Uranium or thorium, or any combination thereof, in any physical or chemical form; or

(2) Ores that contain by weight one-twentieth of 1 percent (0.05 percent) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.

"Source material milling" means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material, of this part.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

"Special form radioactive material" means radioactive material that satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(2) The piece or capsule has at least one dimension not less than 5 millimeters (0.2 inch); and

(3) It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after June 30, 1985, must meet requirements of this definition applicable at the time of its design or construction.

"Special nuclear material" means:

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Nuclear Regulatory Commission, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

(2) Any material artificially enriched by any of the foregoing but does not include source material.

“Standard Internationale (SI)” means the international metric systems of measurement.

"Supplied-air respirator (SAR)" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.

"Test" means the process of verifying compliance with an applicable regulation.

"These regulations" means all parts of The Delaware Radiation Control Regulations 4465, as amended.

"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

"Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in D.1107a.vi. of these regulations.

"Traceable to a National Standard" [See "Instrument traceability" or "Source traceability"].

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing such as grinding, roasting, beneficiating, or refining.

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.

"User seal check (fit check)" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates.¹2/

“Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code, Chapter 33, Veterinarians, as amended.

"Waste" means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act, as amended (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission.

"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

"Week" means 7 consecutive days starting on Sunday.

"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

"Worker" means an individual engaged in activities under a license or registration issued by the Agency and controlled by a licensee or registrant, but does not include the licensee or registrant.

"Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

"Working level month" (WLM) means an exposure to 1 working level for 170 hours. 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

3.1 Exemptions. An exemption may be granted by the Agency if, based on documented and publicly available information, the Agency has verified that the proposed exempted practice or equipment does not pose any danger to the applicant, his employees or any others coming into contact with the exempted practice or equipment. An exemption request that deviates from accepted standards as specified in the regulations, such that the safe use of said practice or equipment cannot be supported by extraneous documented and publicly available information must be referred to the Authority on Radiation Protection for consideration.

3.1.1 General Provision. The Agency as the Agent for the Authority on Radiation Protection may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of the regulations as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

3.1.2 Department of Energy Contractors and Nuclear Regulatory Commission Contractors. Any Department of Energy contractor or subcontractor and any Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this State is exempt from the regulations to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers, or acquires sources of radiation:

3.1.2.1 Prime contractors performing work for the Department of Energy at U.S. Government-owned or -controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

3.1.2.2 Prime contractors of the Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof;

3.1.2.3 Prime contractors of the Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and

3.1.2.4 Any other prime contractor or subcontractor of the Department of Energy or of the Nuclear Regulatory Commission when the State and the Nuclear Regulatory Commission jointly determine:

3.1.2.4.1 That the exemption of the prime contractor or subcontractor is authorized by law; and

3.1.2.4.2 That, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

4.1 Records. Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in the regulations.

4.2 Inspections

4.2.1 Each licensee and registrant shall afford the Agency at all reasonable times opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.

4.2.2 Each licensee and registrant shall make available to the Agency for inspection, upon reasonable notice, records maintained pursuant to the regulations.

4.3 Tests. Each licensee and registrant shall perform upon instructions from the Agency, or shall permit the Agency to perform, such reasonable tests as the Agency deems appropriate or necessary including, but not limited to, tests of:

4.3.1 Sources of radiation;

4.3.2 Facilities wherein sources of radiation are used or stored;

4.3.3 Radiation detection and monitoring instruments; and

4.3.4 Other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.

The Authority through the Agency may, by rule, regulation, or order, impose upon any licensee or registrant such requirements in addition to those established in the regulations as it deems appropriate or necessary to minimize danger to public health and safety or property.

6.1 Violations. An injunction or other court order may be obtained prohibiting any violation of any provision of the State Radiation Control Act, as amended or any regulation or order issued thereunder. The Authority may request the Attorney General to make application to the Court of Chancery for an order enjoining any acts or practices which constitute or will constitute a violation of any provision of this chapter or any rule, regulation or order issued thereunder.

6.2 Impounding. Sources of radiation shall be subject to impoundment pursuant to Title 16 Delaware Code, Section 7415 of the State Radiation Control Act, as amended.

6.3 Prohibited Uses

6.3.1 A hand-held fluoroscopic screen shall not be used with x-ray equipment unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the Food and Drug Administration, Center for Devices and Radiological Health.

6.3.2 A shoe-fitting fluoroscopic device shall not be used.

6.3.3 A closed end PID (conical position indicating device) shall not be used.

6.3.4 A source of radiation shall not be abandoned.

6.4 Penalties. In addition to any other remedies available to the Authority – the Authority may assess an administrative penalty in an amount not to exceed $500 for a first offense, an amount not to exceed $750 for a subsequent offense. Each violation of this chapter or rules, regulations or orders shall be considered a separate offense.

Except as specifically authorized by the Agency in writing, no interpretation of the regulations by an officer or employee of the Agency other than a written interpretation by the Authority on Radiation Protection will be recognized to be binding upon the Agency.

All communications and reports concerning the regulations, and applications filed thereunder, should be addressed to the Agency at its Office of Radiation Control, Division of Public Health, 417 Federal Street, Dover, DE 19901.

9.1 As used in these regulations, the unit of exposure is the coulomb per kilogram (C/kg) of air. One roentgen is equal to 2.58E-4 coulomb per kilogram of air.

9.2 As used in these regulations, the units of dose are:

9.2.1 Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

9.2.2 Rad is the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram. (0.01 Gy)

9.2.3 Rem is the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)

9.2.4 Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)

9.3 As used in these regulations, the quality factors for converting absorbed dose to dose equivalent are shown in Table I:

9.4 If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in A.13c., 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of these regulations, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.

10.1 For purposes of these regulations, activity is expressed in the SI unit of becquerel (Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit of time.

10.2 One becquerel (Bq) = 1 disintegration or transformation per second (dps or tps).

10.3 One curie (Ci) = 3.7E+10 disintegrations or transformations per second (dps or tps) = 3.7E+10 becquerel (Bq) = 2.22E+12 disintegrations or transformations per minute (dpm or tpm).

Part B Registration of Radiation Source Facilities and Services

This Part provides for:

1.1 The registration of ionizing radiation source facilities, and

1.2 The registration of persons providing ionizing radiation source installation, servicing, and/or other services listed in this Part.

1.3 In addition to the requirements of this Part, all registrants are subject to the applicable provisions of the General Provisions (4465, Part A), Standards for Protection (4465, Part D), and Notices, Instructions and Reports (4465, Part J) and Compliance Procedures (4465, Part K). In addition, some registrants are subject to provisions of the regulations for Industrial Radiography (4465, Part E), Diagnostic X-Rays and Imaging Systems in the Healing Arts (4465, Part F), Analytical Equipment (4465, Part H) or Particle Accelerators (4465, Part I) and Therapeutic Radiation Machines (4465, Part X).

“Agency” means the Division of Public Health, Delaware Department of Health and Social Services.

“CFR” means Code of Federal Regulations.

“Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per 24 Del.C., Ch. 7, Board of Chiropractic, as amended.

“Certificate of Approval to Construct” means a document stipulating that work will be done in accordance to the plans and specifications as approved by the Office of Engineering. If at any point after the issuance of a certificate of Approval To Construct there are any changes made to the plans, the Office of Engineering must be immediately notified for them to take appropriate action.

“Certificate of Approval to Operate” means a document indicating that requirements for operation of a new radiation machine facility have been approved by the Office of Radiation Control, following a pre-operational, on-site inspection.

“Dentist” shall mean a person who is qualified to practice dentistry as prescribed in 24 Del.C., Ch. 11, Dentistry and Dental Hygiene, as amended.

“Facility” means the location, building, vehicle, or complex under one administrative control, at which one or more radiation sources are installed, located and/or used.

“Healing arts” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, veterinary medicine or nursing.

“kVP” or Peak Tube Potential, means the maximum value of the potential difference across the x-ray tube during an exposure. This value is usually included in manufacturer’s technical specification for an x-ray device.

“Licensed Practitioner” means a physician an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state.

“Manager” means the individual working at the facility who is authorized by the owner to sign the application form as the applicant.

“Office of Engineering” means the office in the Delaware Division of Public Health which reviews radiation shielding plans, and issues approval for construction of new radiation machine facilities or rooms.

“Office of Radiation Control” means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.

“Owner/Leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager working at the facility to sign the application form.

"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to 24 Del.C., Ch. 17, Medical Practice Act, as amended.

“Podiatrist” means a person who is qualified to practice podiatry and is licensed under 24 Del.C., Ch. 5, Podiatry, as amended.

“Principal Supervisor” means the Licensed Practitioner responsible for initiating use of x-ray equipment or other device generating ionizing radiation in the healing arts.

“Qualified Expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations, as amended.

“Qualified Medical Physicist” means an individual qualified in accordance with 4465, Part X, Therapeutic Radiation Machines, of these regulations. who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Part X, subsection 3.4, as amended.

“Radiation Source” see source of radiation.

“Radiation Safety Officer” or RSO for a radiation machine facility means an individual assigned to perform radiation safety duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.

“Radiation Service Provider” means company or person who provides radiation services to registered radiation source facilities in Delaware, see Section 9.0 of this Part.

“Source of Radiation” means any radioactive material or any device or equipment emitting, or capable of producing, ionizing radiation.

“Storage” means a condition in which a device or source is not being used for an extended period of time, and has been made inoperable and shall be tagged as out of service.

“Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per 24 Del.C. Ch. 33, Veterinarians, as amended.

All registration permit-holders shall prohibit any person or company from furnishing radiation machine servicing or services to their radiation machine facility until such person provides evidence of registration with the Agency as a provider of services in accordance with Section, 9.0 of this Part.

4.1 Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this regulation, provided that the equivalent dose averaged over an area of 10 square centimeters does not exceed 5 µSv (0.5 millirem) per hour at 5 centimeters from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

4.2 Radiation machines in transit or in storage incident to transit are exempt from the requirements of this Part. This exemption does not apply to the providers of radiation machines for mobile services.

4.3 Domestic television receivers, computer monitors, and electron microscopes are exempt from the registration and notification requirements of this regulation.

5.1 Radiation machine facilities proposed for construction, renovation, or equipment installation after the effective date of this regulation that are designed to house x-ray machines with the potential to generate radiation dose to members of the public equal to or greater than 100 millirem per year, or expose a member of the public to an exposure rate equal to or greater than 2 milliroentgen per hour shall be required to submit a radiation shielding plan prepared by a Qualified Expert who is registered with the Office of Radiation Control as a Radiation Service Provider (see Section 9.0 of this part).

5.1.1 Radiation Machine Facilities or rooms which require a shielding plan include the following modalities:

5.2 New radiation machine facilities or rooms designed to house only x-ray machines that operate at maximum energy less than or equal to 70 kVP shall be exempt from the radiation shielding plan requirement; such devices include but are not limited to the following modalities:

5.2.1 Radiation Machine Facilities or rooms which generally do not require a shielding plan include the following modalities:

5.3 Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations utilizing ionizing radiation sources with maximum energy greater than 70 kVP shall be submitted to the Division of Public Health Office of Engineering for review and approval. The required information is listed in Appendices A and B of this Part and Regulation 4465 Part X, Appendix A, for radiation therapeutic sources.

5.4 The Agency shall require the applicant to utilize the services of a Qualified Expert who is registered with the Agency [see Section 9.0 of this Part] to determine the shielding requirements prior to the plan review and approval. The registered consultant shall provide the shielding information on Form R15A or equivalent to the Office of Engineering, Division of Public Health, which will review the shielding plan and if determined acceptable, will issue a Certificate of Approval to Construct letter to the applicant.

5.5 The issuance of a Certificate of Approval to Construct by the Office of Engineering for radiation shielding plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in Regulations 4465 Part D, (Sections D.201, 207, 208 and 301) of these regulations.

5.6 The Office of Radiation Control, Division of Public Health shall conduct a pre-operational, on-site inspection to evaluate shielding and/or operating conditions prior to issuance of the radiation machine registration permit and Certificate of Approval to Operate.

5.7 The Certificate of Approval to Operate issued by the Office of Radiation Control reflects regulatory compliance at the time of the pre-operational inspection of a new facility, and does not imply or certify the facility beyond the scope of that specific inspection.

5.8 After installation of any radiation machine, the registrant shall maintain for inspection by the Agency:

5.8.1 The maximum rated technique factors of each machine;

5.8.2 A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include:

5.8.2.1 The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or

5.8.2.2 The type and thickness of materials, or lead equivalency, of each protective barrier.

5.9 Radiation machine facilities that initiated design, construction or installation of dental panoramic, cephalometric, or cone beam CT devices prior to the effective date of this regulation shall maintain records of radiation surveys of exposure rate (milliroentgen per hour) levels present in uncontrolled public areas (ie. corridors or alcoves) where members of the public or employees may be present in the facility. If such surveys indicate an exposure rate equal to or greater than 2 millroentgen per hour is possible in uncontrolled public areas while x-ray equipment is in operation the facility shall provide administrative controls to limit the dose to members of the public with a visible barrier to delineate the controlled area.

6.1 Each owner of a radioactive material facility shall:

6.1.1 Apply for registration of such facility with the Agency prior to the receipt, possession, use, sale, transfer, ownership or acquisition of the radioactive material. Application for registration shall be completed on forms furnished by the Agency.

6.1.2 Designate on the application form an individual to be responsible for radiation protection, duties; (Radiation Safety Officer), address of the facility, and for the radioactive material; element name, atomic mass, chemical or physical form and maximum amount to be possessed at any one time.

6.2 Each owner of a radiation machine facility shall:

6.2.1 Apply for registration of such facility with the Agency prior to the operation of a radiation source facility. Application for registration shall be completed on forms furnished by the Agency and shall contain all the information required by the form and accompanying instructions;

6.2.2 Designate on the application form an individual to be responsible for radiation protection duties; (Radiation Safety Officer); per Appendix C of this Part.

6.2.3 A Licensed Practitioner responsible for directing the operation of radiation machines shall be designated on each healing arts x-ray facility application, specifying their Delaware license number and phone number. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner's signature if the facility has more than one licensed practitioner (for example, hospitals, large clinics, or multi-practitioner practices), except where prohibited by State Law.

6.2.4 Prohibit any person from furnishing radiation source servicing or services as described in section. 9.4 of this Part to their radiation source facility, until such person provides evidence that they have been registered with the Agency as a Radiation Service Provider in accordance with section 9.0 of this part.

6.2.5 In any facility regulated by or requiring registration under these regulations, the registration permit-holder shall allow only individuals who are adequately trained in radiation safety and the safe and effective use of the machine to operate any radiation machine.

6.2.5.1 The facility registration permit-holder shall document evaluation of the qualifications of each individual permitted to operate any radiation machine at the facility.

6.2.5.1.1 Each operator shall meet all radiation safety training and experience requirements of the respective State of Delaware professional licensure board, as applicable, and any applicable requirements of these regulations (4465 Part B), and 4466 Radiation Technologist/Technician Certification Regulations.

7.1 In addition to the requirements of Section 6.0 of this Part, the applicant shall submit the following information:

7.1.1 An established main location where the machine(s), records, etc. will be maintained for inspection. This shall be a street address, not a post office box number.

7.1.2 A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's location; and

7.1.3 A current copy of the applicant's operating and safety procedures including radiological practices for protection of patients, operators, employees, and the general public.

8.1 In addition to the requirements of 6.0 of this Part each applicant shall apply for and receive authorization for healing arts screening before initiating a screening program. The information and evaluation in Appendix E of this part shall be submitted with the application.

8.2 In addition to the requirements of 6.0 of this Part, any research using radiation machines on humans shall be approved by an Institutional Review Board (IRB) as required by Title 45, CFR, Part 46 and Title 21, CFR, Part 56, as amended.

9.1 Each person or company who is engaged in the business of installing or offering to install radiation machines or is engaged in the business of furnishing or offering to furnish radiation machine servicing or services in this State shall apply for registration of such services with the Agency, and receive Agency approval prior to furnishing or offering to furnish any such services.

9.2 Application for registration shall be completed on forms furnished by the Agency and shall contain all information required by the Agency as indicated on the forms and accompanying instructions.

9.3 Each Radiation Service Provider applying for registration under this regulation shall specify:

9.3.1 That they have read and understand the requirements of this and other applicable regulations;

9.3.2 The education and training that qualify them to discharge the services for which they are applying for registration.

9.4 For the purpose of section 9.0, services may include but shall not be limited to:

9.4.1 Installation and/or servicing of radiation sources and associated radiation source components;

9.4.2 Calibration of radiation source or radiation measurement instruments or devices;

9.4.3 Radiation protection or health physics consultations or surveys;

9.4.4 Personnel dosimetry services;

9.4.5 Radiation Shielding Plans for X-Ray Rooms; or

9.4.6 Practice as a Qualified Medical Physicist.

9.5 No individual working as a Radiation Service Provider shall perform services which are not specifically authorized for that individual by the Agency.

10.1 Upon a determination that an applicant meets the requirements of the regulations, the Agency shall issue a notice of registration, which shall be displayed by the registrant in public view.

10.2 The Agency may incorporate in the notice of registration at the time of issuance or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the registrant's receipt, possession, use, sale and/or transfer of ownership responsibility of radiation sources as it deems appropriate or necessary.

Except as provided in Section 12.0 below, each notice of registration shall expire at the end of the specified day in the month and year stated therein.

12.1 Application for renewal of registration shall be filed in accordance with Part B, sSections 6.0, 7.0 and/or 9.0 of this Part.

12.2 In any case in which a registrant not less than 30 days prior to the expiration of his existing notice of registration has filed an application in proper form for renewal, such existing notice of registration shall not expire until the application status has been finally determined by the Agency.

The registrant shall notify the Agency in writing on forms furnished by the Agency before making any change which would render the information contained in the application for registration and/or the notice of registration no longer accurate. The Agency shall incorporate such changes and issue a corrected registration if necessary.

No person, in any advertisement, shall refer to the fact that he or his facility is registered with the Agency pursuant to the provisions of Part B, sections Section 6.0 or 9.0, and no person shall state or imply that any activity under such registration has been approved by the Agency.

15.1 Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation sources in this State shall notify the Agency within 15 days of:

15.1.1 The name and address of persons who have received these sources;

15.1.2 The manufacturer, model, and serial number of each radiation source transferred; and

15.1.3 The date of transfer of each radiation source.

15.1.4 In the case of diagnostic x-ray systems which contain certified components, a copy of the assembler's report prepared in compliance with requirements of the Federal diagnostic x-ray standard (21 CFR 1020.30(d)) shall be submitted to the Agency following completion of the assembly. Such report shall suffice in lieu of any other report by the assembler.

15.2 No person shall make, sell, lease, transfer, lend, assemble, or install radiation sources or the supplies used in connection with such machines unless such supplies and equipment when properly placed in operation and used shall meet the requirements of these regulations.

16.1 Whenever any radiation source is to be brought into the State, for any temporary use, the person proposing to bring such source into the State shall submit a complete, prescribed application form to the Agency and must receive Agency approval at least 2 working days before such machine is to be brought into the State. The applicant must receive Agency approval prior to use. The notice shall include:

16.1.1 The number(s) and type(s) of radiation source(s);

16.1.2 The nature, start date, duration, and scope of use;

16.1.3 The exact location(s) where the radiation source is to be used; and

16.1.4 the name(s) of the Delaware licensed practitioner(s) and their professional license number(s) if the sources are used to irradiate human beings;

16.1.5 a copy of the person's home state registration license or equivalent document; and

16.1.6 the name(s) and address(es) where the source user(s) can be reached while in the state.

16.2 The person proposing to bring such out-of-state source into Delaware referred to in section 16.1 shall:

16.2.1 Comply with all applicable regulations of the Agency;

16.2.2 Supply the Agency with such other information as the Agency may reasonably request; and

16.2.3 Not operate within the state on a temporary basis in excess of 90 days. Permission to operate for more than 90 days may be granted by the Agency up to 180 days per year.

In order for the Agency to provide an evaluation, technical advice, and official approval on shielding requirements for a radiation installation, the following information must be submitted to the Office of Engineering in the Division of Public Health. The Agency may require a pre-operational inspection be conducted by the Office of Radiation Control to assure that design and operational safety requirements are met prior to approval of the radiation machine registration permit.

1. The plans showing, as a minimum, the following:

(a) The normal location of the system's radiation port; the port's travel and traverse limits; general direction(s) of the useful beam; locations of any windows and doors or other openings; the location of the operator's booth; and the location of the control panel;

(b) The structural composition and thickness or lead equivalence of all walls, doors, partitions, floor, and ceiling of the room(s) concerned;

(c) The dimensions of the room(s) concerned;

(d) The type of occupancy of all adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, show distance to the closest area(s) where it is likely that individuals may be present;

(e) The make and model of the equipment, the maximum technique factors, and the energy waveform (single phase, three phase, etc.);

(f) The type of examination(s) or treatment(s) which will be performed with the equipment.

2. Information on the anticipated workload of the system(s) in mA-minutes per week.

3. A report showing all basic assumptions used in the development of the shielding specifications.

1. Space Requirements:

(a) The operator shall be allotted not less than 0.70 m2 (7.5 square feet) of unobstructed floor space in the booth;

(b) The operator's booth may be any geometric configuration with no dimension of less than 0.6 m (2 feet);

(c) The space shall be allotted excluding any encumbrance by the x‑ray control panel, such as overhang, cables, or other similar encroachments;

(d) The booth shall be located or constructed such that unattenuated direct scatter radiation originating on the examination table or at the wall-mounted image receptor will not reach the operator's position in the booth.

2. Structural Requirements:

(a) The booth walls shall be permanently fixed barriers of at least 2 m (7 feet) high;

(b) When a door or movable panel is used as an integral part of the booth structure, it must have an interlock which will prevent an exposure when the door or panel is not closed;

(c) Shielding shall be provided to meet the requirements of Part D of these regulations.

3. Radiation Exposure Control Placement:

The radiation exposure control for the system shall be fixed within the booth and:

(a) Shall be at least 1.0 m (40 inches) from any point subject to direct scatter, leakage or primary beam radiation;

(b) Shall allow the operator to use the majority of the available viewing windows.

4. Viewing System Requirements:

(a) Each booth shall have at least one viewing device which will:

(1) Be so placed that the operator can view the patient during any exposure; and

(2) Be so placed that the operator can have full view of any occupant of the room and should be so placed that the operator can view any entry into the room. If any door which allows access to the room cannot be seen from the booth, then outside that door there shall be an "x-ray on" warning sign that will be lighted anytime the rotor of the x-ray tube is activated. Alternatively, an interlock shall be present such that exposures are prevented unless the door is closed.

(b) When the viewing system is a window, the following requirements also apply:

(1) The window shall have a viewing area of at least 0.09 m2 (1 square foot);

(2) Regardless of size or shape, at least 0.09 m2 (1 square foot) of the window area must be centered no less than 0.6 m (2 feet) from the open edge of the booth and no less than 1.5 m (5.0 feet) from the floor;

(3) The window shall have at least the same lead equivalence as that required in the booth's wall in which it is mounted.

(c) When the viewing system is by mirrors, the mirror(s) shall be so located as to accomplish the general requirements of Appendix B4.(a).

(d) When the viewing system is by electronic means:

(1) The camera shall be so located as to accomplish the general requirements of Appendix B4.(a); and

(2) There shall be an alternate viewing system as a backup for the primary system.

The applicant or registration permit-holder, shall require each individual assigned to fulfill responsibilities and duties as Radiation Safety Officer (RSO) to be an individual who has training and experience in the safe and effective use of radiation machines and the potential radiation hazards and emergency precautions applicable to the type(s) of activity or facility for which the individual is seeking to perform RSO duties, to include:

I. Establishing and overseeing operating and safety procedures that maintain radiation exposures as low as reasonably achievable (ALARA), and to review them periodically to ensure that the procedures are current and conform with these regulations;

II. Ensuring that individual monitoring devices are properly used by occupationally exposed personnel as required by the regulations, that records are kept of the monitoring results, and that timely notifications are made as required by 4465 Part D;

III. Investigating and reporting to the agency each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by these regulations and each theft or loss of source(s) of radiation, determining the cause, and taking steps to prevent its recurrence;

IV. Having a thorough knowledge of management policies, administrative procedures and records of the registration permit-holder and keeping management informed on a periodic basis of the performance of the registrant’s radiation protection program, if applicable;

V. Assuming control and having the authority to institute corrective actions including shutdown of operations when necessary in emergency situations or unsafe conditions;

VI. Maintaining records as required by these regulations; and

VII. Ensuring that personnel are adequately trained and complying with these regulations, the conditions of the certificate of registration, and the operating and safety procedures of the registered permit-holder.

All persons performing radiation machine assembly, installation or repair shall meet the general requirements in subparagraph 1. of this paragraph and one or more of the specialized requirements in subparagraph 2. of this paragraph.

1. General requirements include:

(a) Experience or education providing familiarity with the type(s) of equipment to be serviced, to include radiation safety;

(b) Knowledge of protective measures to reduce potentially hazardous conditions; and

(c) Six months of supervised assembly and repair of the type(s) of equipment to be serviced.

2. Specialized requirements include:

(a) One year of formal training (may be satisfied by factory school, military technical training school, or other courses in radiation machine assembly, installation or repair techniques) or an associate's degree in biomedical equipment repair;

(b) A bachelor's degree in electrical engineering with specialized training in radiation producing devices; or

(c) A combination of training and experience equal to clause (a) of this subparagraph.

The following information must be submitted by persons proposing to conduct healing arts screening. Persons requesting that the agency approve a healing arts screening program shall submit the following information and evaluation.

1. Administrative controls to include the following:

(a) The name and address of the applicant and, where applicable, the names and addresses of agents within the state;

(b) The diseases or conditions for which the x‑ray examinations are to be used in diagnoses;

(c) A detailed description of the x‑ray examinations proposed in the screening program;

(d) A description of the population to be examined in the screening program, for example, age, sex, physical condition, and other appropriate information;

(e) An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the x‑ray examination; and

(f) For mobile screening operations, location(s) where radiation machines are used and maintained.

2. Operating procedures for all x-ray systems (except bone densitometers) to include the following:

(a) An evaluation of the x-ray systems to be used in the screening program. The evaluation shall be performed by a licensed medical physicist with a specialty in diagnostic radiological physics. The evaluation shall show that such systems do satisfy all requirements of this section;

(b) A description of the diagnostic imaging quality control program; and

(c) A copy of the technique chart for the x‑ray examination procedures to be used.

3. Operating procedures for bone densitometers to include the manufacturer's evaluation of the system to be used in the screening program. The evaluation shall show that such systems satisfy all requirements of this section.

4. Training data to include the following:

(a) The qualifications of each individual who will be operating the x‑ray systems;

(b) The qualifications of the individual who will be supervising the operators of the x‑ray systems. The extent of supervision and the method of work performance evaluation shall be specified; and

(c) The name and address of the practitioner licensed in the state who will interpret the radiographs.

5. Records to include the following:

(a) A description of the procedures to be used in advising the individuals screened, and their private practitioners of the healing arts, of the results of the screening procedure and any further medical needs indicated; and

(b) A description of the procedures for the retention or disposition of the radiographs and other records pertaining to the x‑ray examinations.

This part provides for the licensing of radioactive material, for purposes of protecting the public health and safety. No person shall receive, possess, use, transfer, sell, own or acquire radioactive material except as authorized in a specific or general license per the U.S. Nuclear Regulatory Commission (NRC), in accordance with Title 10 – Code of Federal Regulations. Primary radioactive material licensing and enforcement authority was transferred to the NRC in 2007, pursuant to the Federal Energy Policy Act of 2005. However, radioactive material facilities must be registered with the State of Delaware in accordance with 4481/Part B of these regulations.

STANDARDS FOR PROTECTION AGAINST RADIATION

General Provisions

1.1 Part D establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the Agency. These regulations are issued pursuant to the Title 16, Delaware Code, Chapter 74 Radiation Control.

1.2 The requirements of Part D are designed to control the receipt, possession, use, sale, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in Part D. However, nothing in Part D shall be construed as limiting actions that may be necessary to protect health and safety.

Except as specifically provided in other Parts of these regulations, Part D applies to persons licensed or registered by the Agency to receive, possess, use, sell, transfer, or dispose of sources of radiation. The limits in Part D do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with the providers ALARA license conditions, or to voluntary participation in medical research programs.

As used in Part D:

"A1" means the maximum activity of special form radioactive material permitted in a Type A package.

"A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package.

These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.

“Absorbed dose” means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

“Accelerator” means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.

“Accelerator-produced material” means any material made radioactive by a particle accelerator.

“Activity” means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

“Address of use” means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.

"Adult" means an individual 18 or more years of age.

“Agency” means the Division of Public Health, Delaware Department of Health and Social Services.

“Agreement State” means any State with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

“Airborne radioactive material” means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

“Airborne radioactivity area” means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(1) In excess of the derived air concentrations (DAC's) specified in Appendix B, Table I of Part D of these regulations; or

(2) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours.

“Airline respirator” (see "Supplied-air respirator (SAR)").

“Air-purifying respirator” means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

“Annual limit on intake (ALI)” means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent to 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Appendix B of this regulation.

“As low as is reasonably achievable” (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.

“Assigned Protection Factor (APF)” means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

“Atmosphere-supplying respirator” means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.

“Authorized user” means a practitioner of the healing arts who is identified as an authorized user on an Agency, Agreement State, Licensing State or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.

“Background radiation” means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Agency.

"Becquerel" (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).

"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term.

"Brachytherapy" means a method of radiation therapy in which radiation sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.

"Byproduct material" means:

(1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material;

(2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

(3) (i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or

(ii) Any material that—

(A) Has been made radioactive by use of a particle accelerator; and

(B) Is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; and

(4) Any discrete source of naturally occurring radioactive material, other than source material, that—

(i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

(ii) Before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical, or research activity.

“Calendar quarter” means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.

“Calibration” means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.

“CFR” means Code of Federal Regulations.

“Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per Title 24 Delaware Code, Chapter 7, Board of Chiropractic, as amended.

“Class (or lung class or inhalation class)” means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days.

“Collective dose” means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

“Committed dose equivalent” (HT.50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

“Committed effective dose equivalent” (HE.50) is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = Σ wT HT,50).

“Constraint (dose constraint)” means a value above which specified licensee actions are required.

“Controlled area” means an area, outside of a restricted but inside the site boundary, access to which can be limited by the licensee or registrant, for any reason.

“Critical group” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

“Curie” means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).

“Declared pregnant woman” means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

“Deep dose equivalent” (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).

“Demand respirator” means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation

“Dentist” shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code, Chapter 11, Dentistry and Dental Hygiene, as amended.

“Department of Energy” means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and re-transferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)

"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

“Derived air concentration (DAC)” means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one ALI. DAC values are given in Appendix B of this regulation.

“Discrete Source” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.

"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

"Dose equivalent (HT)" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

"Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.

"Effective dose equivalent (HE)" means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).

"Embryo/fetus" means the developing human organism from conception until the time of birth.

"Exposure" generally means being exposed to ionizing radiation or to radioactive material;

"Exposure Units" specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Section 9.1 of Part A for Units of Exposure and Dose.

"Exposure rate" means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.

"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

“External Source” means all ionizing radiation sources that could present exposure or external dose to an individual.

"Extremity" means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.

“Facility” means the location, building vehicle, or complex under one administrative control, at which one or more radiation sources are installed, located and/or used.

"Filtering facepiece (dust mask)" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

"Fit Test" means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.

"Former Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory Commission licenses have been terminated.

"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

"Gray" (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).

"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.

“Healing arts” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.

“Healing arts screening” means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.

"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.

"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

"Human use" means the internal or external administration of radiation or radioactive material to human beings.

"Individual" means any human being.

"Individual monitoring" means the assessment of:

(1) Dose equivalent (a) by the use of individual monitoring devices or (b) by the use of survey data; or

(2) Committed effective dose equivalent (a) by bioassay or (b) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. [See the definition of DAC-hours in 4465 Part D of these regulations.]

(3) Dose equivalent by the use of survey data.

"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.

"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.

"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.

"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

"JRCECT" means Joint Review Committee on Education in Cardiovascular Technology

“JRCNMT” means Joint Review Committee on Nuclear Medicine Technology

"JRCERT" means Joint Review Committee on Education in Radiologic Technology

"Lens dose equivalent (LDE)" means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).

"License" means a license issued by the US Nuclear Regulatory Commission, Agreement State, or the Agency, in accordance with applicable federal or state regulations, as amended.

"Licensed [or registered] material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.

“Licensed Practitioner” means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, advanced practice nursing, or veterinary medicine in this state.

"Licensee" means the holder of a license.

"Limits" [See "Dose limits"].

"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

"Lost or missing source of radiation" means licensed [or registered] source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in T.2 of these regulations.

"Member of the public" means any individual except when that individual is receiving an occupational dose.

"Minor" means an individual less than 18 years of age.

“Misadministration” means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, Section 5.2 of these regulations.

"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.

"Natural radioactivity" means radioactivity of naturally occurring nuclides.

"Negative pressure respirator (tight fitting)" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

"NORM" means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.

“Notice of Violation” means a written statement of one or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:

Corrective steps taken by the licensee, registrant or other permit holder and the results achieved;

Corrective steps to be taken to prevent recurrence; and

The projected date for achieving full compliance. The Authority may require responses to notices of violation to be under oath.

"NRC" means the US Nuclear Regulatory Commission or its duly authorized representatives.

"Occupational dose" means the dose received by an individual in the course of employment, education or training, in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.

“Office of Engineering” means the office in the Delaware Division of Public Health that reviews radiation shielding plans and/or design plans and issues an Approval to Construct letter for new radiation source facilities or rooms.

“Office of Radiation Control” means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.

“Owner/Leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager to sign the application form.

"Package" means the packaging together with its radioactive contents as presented for transport.

"Particle accelerator" [See "Accelerator"].

"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other State or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].

"Personnel monitoring equipment" [See "Individual monitoring devices"].

"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.

“Planned special exposure” means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

“Podiatrist” means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.

"Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

"Powered air-purifying respirator (PAPR)" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

“Principal Supervisor” means the State-Licensed Practitioner responsible for initiating use of x-ray equipment or other device generating ionizing radiation in the healing arts.

"Protective apron" means an apron made of radiation-attenuating materials used to reduce exposure to radiation.

"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.

“Qualified expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations, as amended.

“Qualified Medical Physicist” means an individual qualified in accordance with Regulation 4465, Part X, Therapeutic Radiation Machines, Section 3.4, as amended. who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Part X, subsection 3.4, as amended.

“Qualitative fit test (QLFT)" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.

"Quality factor" (Q) means the modifying factor, listed in Tables I and II of A.13, that is used to derive dose equivalent from absorbed dose.

"Quantitative fit test (QNFT)" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

"Rad" means the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).

"Radiation" means alpha particles, beta particles, gamma rays, x rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.

"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

"Radiation dose" [See "Dose"].

"Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

“Radiation Safety Officer” or RSO for a radiation machine facility means an individual assigned to perform RSO duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.

"Radiation Technician" means any individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.

"Radiation Technologist" means any individual who has successfully completed a JRCERT/JRCCVT approved program in radiation technology and has passed a national certification examination in his/her field of specialization.

"Radiation Technology" means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.

"Radioactive material" means any solid, liquid or gas which emits radiation spontaneously.

"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

"Radiobioassay" [See "Bioassay"].

"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to these regulations and the Act.

“Registration" means registration with the Agency in accordance with the regulations adopted by the Agency.

"Regulations of the Department of Transportation" means the regulations in 49 CFR Parts 100-189, as amended.

"Rem" means the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)

"Research and development" means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings in the healing arts.

"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee’s control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of these regulations.

"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

"Roentgen" means the traditional unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and Part A.9.1 of this part.)

“State Radiation Control Act” or “the Act” means Title 16 Delaware Code, Chapter 74, Radiation Control, as amended.

"Sealed source" means any encapsulated radioactive material, which has been constructed in such a manner as to prevent the escape of any radioactive material.

"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC), that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.

"Self-contained breathing apparatus (SCBA)" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

"Shallow dose equivalent" (Hs), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.

"SI" means the abbreviation for Standard Internationale, the International Metric System of Measurement.

"Sievert" means the Standard Internationale (SI) unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)

"Source material" means:

(1) Uranium or thorium, or any combination thereof, in any physical or chemical form; or

(2) Ores that contain by weight one-twentieth of 1 percent (0.05 percent) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.

"Source material milling" means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material, of this part.

"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.

"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.

"Special form radioactive material" means radioactive material that satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(2) The piece or capsule has at least one dimension not less than 5 millimeters (0.2 inch); and

(3) It satisfies the test requirements specified by the Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation either designed or constructed after June 30, 1985, must meet requirements of this definition applicable at the time of its design or construction.

"Special nuclear material" means:

(1) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the Nuclear Regulatory Commission, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

(2) Any material artificially enriched by any of the foregoing but does not include source material.

"Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula:

For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material.

The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:

“Standard Internationale (SI)” means the international metric systems of measurement.

"Supplied-air respirator (SAR)" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.

"Test" means the process of verifying compliance with an applicable regulation.

"These regulations" means all parts of The Delaware Radiation Control Regulations 4465, as amended.

"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

"Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

"Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in subsection 39.1.6 of these regulations.

"Traceable to a National Standard" [See "Instrument traceability" or "Source traceability"].

"Unrefined and unprocessed ore" means ore in its natural form prior to any processing such as grinding, roasting, beneficiating, or refining.

"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.

"User seal check (fit check)" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates.²2/

“Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code, Chapter 33, Veterinarians, as amended.

"Waste" means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act, as amended (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission.

"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

"Week" means 7 consecutive days starting on Sunday.

"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

"Worker" means an individual engaged in activities under a license or registration issued by the Agency and controlled by a licensee or registrant, including but not limited to employees, but does not include the licensee or registrant.

"Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.

"Working level month" (WLM) means an exposure to 1 working level for 170 hours. 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.

4.1 Any existing license or registration condition that is more restrictive than Part D remains in force until there is an amendment or renewal of the license or registration.

4.2 If a license or registration condition exempts a licensee or registrant from a provision of Part D in effect on or before the effective date of these regulations, it also exempts the licensee or registrant from the corresponding provision of Part D.

4.3 If a license or registration condition cites provisions of Part D in effect prior to the effective date of these regulations, which do not correspond to any provisions of Part D, the license or registration condition remains in force until there is an amendment or renewal of the license or registration that modifies or removes this condition.

Radiation Protection Programs

5.1 Each licensee or registrant shall develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of Section 35.0 for recordkeeping requirements relating to these programs.

5.2 The licensee or registrant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA).

5.3 The licensee or registrant shall, at intervals not to exceed 12 months, review the radiation protection program content and implementation.

5.4 To implement the ALARA requirements of subsection 5.2, and notwithstanding the requirements in Section 13.0, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to 10 CFR Part 50.34a of the USNRC regulations, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 0.1 millisievert (10 mrem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in Section 47.0 and promptly take appropriate corrective action to ensure against recurrence.

Occupational Dose Limits

6.1 The licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures pursuant to Section 10.0, to the following dose limits:

6.1.1 An annual limit, which is the more limiting of:

6.1.1.1 The total effective dose equivalent being equal to 0.05 Sievert (5 rem, or 5000 millirem); or

6.1.1.2 The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 Sievert (50 rem, or 50,000 millirem).

6.1.2 The annual limits to the lens of the eye, to the skin, and to the extremities which are:

6.1.2.1 A lens dose equivalent of 0.15 Sievert (15 rem, or 15,000 millirem); and

6.1.2.2 A shallow dose equivalent of 0.5 Sievert (50 rem, or 50,000 millirem) to the skin or to any extremity.

6.2 Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See subsections 10.1.5.1 and 10.1.5.2.

6.3 The assigned deep dose equivalent and shallow dose equivalent shall be for the portion of the body receiving the highest exposure:

6.3.1 The deep dose equivalent, lens dose equivalent and shallow dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

6.3.2 When a protective apron is worn while working with medical fluoroscopic equipment and monitoring is conducted as specified in subsection 17.1.1.5, the effective dose equivalent for external radiation shall be determined as follows:

6.3.2.1 When only one individual monitoring device is used and it is located at the neck (collar) outside the protective apron, the reported deep dose equivalent shall be the effective dose equivalent for external radiation;

6.3.2.2 When only one individual monitoring device is used and it is located at the neck (collar) outside the protective apron, and the reported dose exceeds 25 percent of the limit specified in subsection 6.1 the reported deep dose equivalent value multiplied by 0.30 shall be the effective dose equivalent for external radiation; or

6.3.2.3 When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04.

6.4 Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in Table I of Appendix B and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See Section 39.0.

6.5 In addition to the annual dose limits, the licensee or registrant shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity. See footnote c/ of Appendix B.

6.6 The licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person during the current year. See Section 37.0.

7.1 If the licensee or registrant is required to monitor pursuant to both subsections 17.1.1 and 17.1.2 the licensee or registrant shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee or registrant is required to monitor only pursuant to subsection 17.1.1 or only pursuant to subsection 17.1.2, then summation is not required to demonstrate compliance with the dose limits. The licensee or registrant may demonstrate compliance with the requirements for summation of external and internal doses pursuant to subsections 7.2, 7.3 and 7.4. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

7.2 Intake by Inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity:

7.2.1 The sum of the fractions of the inhalation ALI for each radionuclide; or

7.2.2 The total number of derived air concentration-hours (DAC- hours) for all radionuclides divided by 2,000; or

7.2.3 The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, wT, and the committed dose equivalent, HT,50, per unit intake is greater than 10 percent of the maximum weighted value of HT,50, that is, wTHT,50, per unit intake for any organ or tissue.

7.3 Intake by Oral Ingestion. If the occupationally exposed individual receives an intake of radionuclides by oral ingestion greater than 10 percent of the applicable oral ALI, the licensee or registrant shall account for this intake and include it in demonstrating compliance with the limits.

7.4 Intake through Wounds or Absorption through Skin. The licensee or registrant shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be evaluated.

8.1 Licensees or registrants shall, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, lense dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See Appendix B, footnotes a/ and b/.

8.2 Airborne radioactivity measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices.

9.1 For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee or registrant shall, when required pursuant to Section 17.0, take suitable and timely measurements of:

9.1.1 Concentrations of radioactive materials in air in work areas;

9.1.2 Quantities of radionuclides in the body;

9.1.3 Quantities of radionuclides excreted from the body; or

9.1.4 Combinations of these measurements.

9.2 Unless respiratory protective equipment is used, as provided in Section 24.0, or the assessment of intake is based on bioassays, the licensee or registrant shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

9.3 When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee or registrant may:

9.3.1 Use that information to calculate the committed effective dose equivalent, and, if used, the licensee or registrant shall document that information in the individual's record;

9.3.2 Upon prior approval of the Agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

9.3.3 Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See Appendix B.

9.4 If the licensee or registrant chooses to assess intakes of Class Y material using the measurements given in 9.1.2 or 9.1.3, the licensee or registrant may delay the recording and reporting of the assessments for periods up to 7 months, unless otherwise required by Sections 46.0 or 47.0. This delay permits the licensee or registrant to make additional measurements basic to the assessments.If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC- hours shall be either:

9.4.1 The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from Appendix B for each radionuclide in the mixture; or

9.4.2 The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

9.5 If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture.

9.6 When a mixture of radionuclides in air exists, a licensee or registrant may disregard certain radionuclides in the mixture if:

9.6.1 The licensee or registrant uses the total activity of the mixture in demonstrating compliance with the dose limits in Section 6.0 and in complying with the monitoring requirements in subsection 7.2;

9.6.2 The concentration of any radionuclide disregarded is less than 10 percent of its DAC; and

9.6.3 The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30 percent.

9.7 When determining the committed effective dose equivalent, the following information may be considered:

9.7.1 In order to calculate the committed effective dose equivalent, the licensee or registrant may assume that the inhalation of one ALI, or an exposure of 2,000 DAC- hours, results in a committed effective dose equivalent of 0.05 Sievert (5 rem, or 5000 millirem) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent;

9.7.2 For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 Sievert (50 rem, or 50,000 millirem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 Sievert (5 rem, or 5000 millirem), that is, the stochastic ALI, is listed in parentheses in Table I of Appendix B. The licensee or registrant may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee or registrant uses the stochastic ALI, the licensee or registrant shall also demonstrate that the limit in subsection 6.1.1.2 is met.

10.1 A licensee or registrant may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in Section 6.0 provided that each of the following conditions is satisfied:

10.1.1 The licensee or registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical;

10.1.2 The licensee or registrant, and employer if the employer is not the licensee or registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

10.1.3 Before a planned special exposure, the licensee or registrant ensures that each individual involved is:

10.1.3.1 Informed of the purpose of the planned operation;

10.1.3.2 Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

10.1.3.3 Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

10.1.4 Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant ascertains prior doses as required by subsection 37.2 during the lifetime of the individual for each individual involved;

10.1.5 Subject to subsection 6.2, the licensee or registrant shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

10.1.5.1 The numerical values of any of the dose limits in subsection 6.1 in any year; and

10.1.5.2 Five times the annual dose limits in subsection 6.1 during the individual's lifetime;

10.1.6 The licensee or registrant maintains records of the conduct of a planned special exposure in accordance with Section 38.0 and submits a written report in accordance with Section 48.0;

10.1.7 The licensee or registrant records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to subsection 6.1 but shall be included in evaluations required by subsections 10.1.4 and 10.1.5.

The annual occupational dose limits for minors are 10 percent of the annual occupational dose limits specified for adult workers in Section 6.0.

12.1 The licensee or registrant shall ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 5 millisievert (0.5 rem, or 500 millirem). See subsection 39.4 for recordkeeping requirements. See Appendix D for “Sample Letter for Declaring Pregnancy - Confidential, Protected Health Information”.

12.2 The licensee or registrant shall make efforts to avoid substantial variation*/ above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in subsection 12.1.

12.3 The dose equivalent to the embryo/fetus is the sum of:

12.3.1 The deep dose equivalent to the declared pregnant woman; and

12.3.2 The dose equivalent resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.

12.4 If the dose equivalent to the embryo/fetus is found to have exceeded 5 millisieverts (0.5 rem, or 500 millirem), or is within 0.5 millisieverts (0.05 rem, or 50 millirem) of this dose, by the time the woman declares the pregnancy to the licensee or registrant, the licensee or registrant shall be deemed to be in compliance with subsection 12.1. if the additional dose to the embryo/fetus does not exceed 0.5 millisievert (0.05 rem, or 50 millirem) during the remainder of the pregnancy.

Radiation Dose Limits for

Individual Members of the Public

13.1 Each licensee or registrant shall conduct operations so that:

13.1.1 The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 millisievert (0.1 rem, or 100 millirem) in a year, exclusive of the dose contribution from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with their health care providers ALARA license conditions, from voluntary participation in medical research programs, and from the licensee's or registrant's disposal of radioactive material into sanitary sewerage in accordance with D.2003;**/ and

13.1.2 The dose in any unrestricted area from external sources exclusive of the dose contributions from patients administered radioactive material and released in accordance with their health care providers ALARA license conditions, does not exceed 0.02 millisievert (0.002 rem, or 2 millirem) in any one hour; and

13.2 If the licensee or registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals.

13.3 A licensee, registrant, or an applicant for a license or registration may apply for prior Agency authorization to operate up to an annual dose limit for an individual member of the public of 5 millisievert (0.5 rem, or 500 millirem). This application shall include the following information:

13.3.1 Demonstration of the need for and the expected duration of operations in excess of the limit in subsection 13.1;

13.3.2 The licensee's or registrant's program to assess and control dose within the 5 millisieverts (0.5 rem or 500 millirem) annual limit; and

13.3.3 The procedures to be followed to maintain the dose as low as is reasonably achievable (ALARA).

13.4 In addition to the requirements of Part D, a licensee or registrant subject to the provisions of the Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190 shall comply with those standards.

13.5 The Agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee or registrant may release in effluents in order to restrict the collective dose.

14.1 The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public in Section 13.0

14.2 A licensee or registrant shall show compliance with the annual dose limit in Section 13.0 by:

14.2.1 Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

14.2.2 Demonstrating that:

14.2.2.1 The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in Table II of Appendix B; and

14.2.2.2 If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert (0.002 rem, or 2 millirem) in an hour and 0.5 millisievert (0.05 rem, or 50 millirem) in a year.

14.3 Upon approval from the Agency, the licensee or registrant may adjust the effluent concentration values in Appendix B, Table II, for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form.

Testing for Leakage or Contamination of Sealed Sources

The licensee or registrant in possession of any sealed source shall perform leak testing of sealed sources in accordance with their radioactive material license conditions.

Surveys and Monitoring

16.1 Each licensee or registrant shall make, or cause to be made, surveys that:

16.1.1 Are necessary for the licensee or registrant to comply with Part D; and

16.1.2 Are necessary under the circumstances to evaluate:

16.1.2.1 The magnitude and extent of radiation levels;

16.1.2.2 Concentrations or quantities of radioactive material; and

16.1.2.3 The potential radiological hazards.

16.2 The licensee or registrant shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are calibrated at intervals not to exceed 12 months for the radiation measured, except when a more frequent interval is specified in another applicable Part of these regulations or a license condition.

16.3 All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by licensees and registrants to comply with Section 6.0, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor:

16.3.1 Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program of the National Institute of Standards and Technology; and

16.3.2 Approved in this accreditation process for the type of radiation or radiations included in the National Voluntary Laboratory Accreditation Program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.

16.4 The licensee or registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device.

17.1 Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of Part D. As a minimum:

17.1.1 Each licensee or registrant shall monitor occupational exposure to radiation from radiation sources under its control and shall supply and require the use of individual monitoring devices by:

17.1.1.1 Adults likely to receive, in 1 year from sources external to the body, a dose in excess of 10 percent of the limits in subsection 6.1;

17.1.1.2 Minors likely to receive, in 1 year from sources external to the body, a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem), a lens dose equivalent in excess of 1.5 millisievert (0.15 rem, or 150 millirem), or a shallow dose equivalent to the skin or to the extremities in excess of 5 millisievert (0.5 rem, or 500 millirem);

17.1.1.3 Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem);

17.1.1.4 Individuals entering a high or very high radiation area; and

17.1.1.5 Individuals working with medical fluoroscopic equipment.

17.1.1.5.1 An individual monitoring device used for the dose to an embryo/fetus of a declared pregnant woman, pursuant to subsection 12.1, shall be located under the protective apron at the waist.

17.1.1.5.2 An individual monitoring device used for lense dose equivalent shall be for external radiation pursuant to subsection 6.3.2, it shall be located at the neck (collar) outside the protective apron. When a second individual monitoring device is used for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.

17.1.2 Each licensee or registrant shall monitor, to determine compliance with Section 9.0, the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

17.1.2.1 Adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable ALI in Table I, Columns 1 and 2, of Appendix B;

17.1.2.2 Minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 0.1 millisievert (0.01 rem, or 100 millirem); and

17.1.2.3 Declared pregnant women likely to receive, during the entire pregnancy, a committed dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem).

18.1 Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with subsection 17.1.1 wear individual monitoring devices as follows:

18.1.1 An individual monitoring device used for monitoring the dose to the whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar);

18.1.2 An individual monitoring device used for monitoring the dose to an embryo/fetus of a declared pregnant woman, pursuant to subsection 12.1, shall be located at the waist under any protective apron being worn by the woman;

18.1.3 An individual monitoring device used for monitoring the lens dose equivalent, to demonstrate compliance with subsection 6.1.2.1, shall be located at the neck (collar), outside any protective apron being worn by the monitored individual, or at an unshielded location closer to the eye;

18.1.4 An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with subsection 6.1.2.2, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

Control of Exposure from External Sources in Restricted Areas

19.1 The licensee or registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features:

19.1.1 A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates;

19.1.2 A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

19.1.3 Entryways that are locked, except during periods when access to the areas is required, with control over each individual entry.

19.2 In place of the controls required by subsection 19.1 for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

19.3 The licensee or registrant may apply to the Agency for approval of alternative methods for controlling access to high radiation areas.

19.4 The licensee or registrant shall establish the controls required by subsections 19.1 and 19.3 in a way that does not prevent individuals from leaving a high radiation area.

19.5 The licensee or registrant is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in Part D and to operate within the ALARA provisions of the licensee's or registrant's radiation protection program.

19.6 The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in Section 19.0 if the registrant has met all the specific requirements for access and control specified in other applicable Parts of these regulations, such as, Part E for industrial radiography, Part F for X-rays in the healing arts, and Part I for particle accelerators.

20.1 In addition to the requirements in Section 19.0, the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 5 gray (500 rad) or more in 1 hour at 1 meter from a source of radiation or any surface through which the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic X-ray systems are the only source of radiation, or to non-self-shielded irradiators.

20.2 The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in subsection 20.1. if the registrant has met all the specific requirements for access and control specified in other applicable Parts of these regulations, such as, Part E for industrial radiography, Part F for X-rays in the healing arts, and Part I for particle accelerators.

21.1 Section 21.0 applies to licensees or registrants with sources of radiation in non-self- shielded irradiators. Section 21.0 does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in completely self- shielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual.

21.2 Each area in which there may exist radiation levels in excess of 5 gray (500 rad) in 1 hour at 1 meter from a source of radiation that is used to irradiate materials shall meet the following requirements:

21.2.1 Each entrance or access point shall be equipped with entry control devices which:

21.2.1.1 Function automatically to prevent any individual from inadvertently entering a very high radiation area;

21.2.1.2 Permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour; and

21.2.1.3 Prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour.

21.2.2 Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by subsection 21.2.1:

21.2.2.1 The radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour; and

21.2.2.2 Conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices.

21.2.3 The licensee or registrant shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container:

21.2.3.1 The radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 millisievert (0.1 rem, or 100 millirem) in 1 hour; and

21.2.3.2 Conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or registrant or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier.

21.2.4 When the shield for stored sealed sources is a liquid, the licensee or registrant shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding.

21.2.5 Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of subsections 21.2.3 and 21.2.4.

21.2.6 Each area shall be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source of radiation from being put into operation.

21.2.7 Each area shall be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation.

21.2.8 Each area shall be checked by a radiation measurement to ensure that, prior to the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 millisievert (0.1 rem or 100 millirem) in 1 hour.

21.2.9 The entry control devices required in subsection 21.2.1 shall be tested for proper functioning. See Section 42.0 for recordkeeping requirements.

21.2.9.1 Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day;

21.2.9.2 Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption; and

21.2.9.3 The licensee or registrant shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.

21.2.10 The licensee or registrant shall not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly.

21.2.11 Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, shall be controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials shall be equipped to detect and signal the presence of any loose radioactive material that is carried toward such an exit and automatically to prevent loose radioactive material from being carried out of the area.

21.3 Licensees, registrants, or applicants for licenses or registrations for sources of radiation within the purview of subsection 21.2 which will be used in a variety of positions or in locations, such as open fields or forests, that make it impracticable to comply with certain requirements of subsection 21.2, such as those for the automatic control of radiation levels, may apply to the Agency for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in subsection 21.2. At least one of the alternative measures shall include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used.

21.4 The entry control devices required by subsections 21.2 and 21.3 shall be established in such a way that no individual will be prevented from leaving the area.

Respiratory Protection and Controls to Restrict

Internal Exposure in Restricted Areas

The licensee or registrant shall use, to the extent practical, process or other engineering controls, such as, containment, decontamination or ventilation, to control the concentrations of radioactive material in air.

23.1 When it is not practicable to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee or registrant shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means:

23.1.1 Control of access;

23.1.2 Limitation of exposure times;

23.1.3 Use of respiratory protection equipment; or

23.1.4 Other controls.

23.2 If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may also consider the impact of respirator use on workers' industrial health and safety.

24.1 If the licensee or registrant uses respiratory protection equipment to limit intakes pursuant to Section 23.0:

24.1.1 Except as provided in subsection 24.1.2, the licensee or registrant shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health;

24.1.2 If the licensee or registrant wishes to use equipment that has not been tested or certified by the National Institute for Occupational Safety and Health, or for which there is no schedule for testing or certification, the licensee shall submit an application to the Agency for authorized use of this equipment, except as otherwise noted in this Part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by the licensee's or registrant's testing or on the basis of reliable test information;

24.1.3 The licensee or registrant shall implement and maintain a respiratory protection program that includes:

24.1.3.1 Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;

24.1.3.2 Surveys and bioassays, as necessary, to evaluate actual intakes;

24.1.3.3 Testing of respirators for operability (user seal check for face sealing devices and functional check for others) immediately prior to each use; and

24.1.3.4 Written procedures regarding:

24.1.3.4.1 Monitoring, including air sampling and bioassays;

24.1.3.4.2 Supervision and training or respirator users;

24.1.3.4.3 Fit testing;

24.1.3.4.4 Respirator selection;

24.1.3.4.5 Breathing air quality;

24.1.3.4.6 Inventory and control;

24.1.3.4.7 Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;

24.1.3.4.8 Recordkeeping; and

24.1.3.4.9 Limitations on periods of respirator use and relief from respirator use.

24.1.3.5 Determination by a physician that the individual user is medically fit to use the respiratory protection equipment before:

24.1.3.5.1 The initial fitting of a face sealing respirator;

24.1.3.5.2 Before the first field use of non- face sealing respirators, and

24.1.3.5.3 Either every 12 months thereafter, or periodically at a frequency determined by a physician.

24.1.3.6 Fit testing, with a fit factor 10 times the APF for negative pressure devices, and a fit factor 500 for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight fitting, face sealing respirators and periodically thereafter at a frequency not to exceed 1 year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

24.1.4 The licensee or registrant shall advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

24.1.5 The licensee or registrant shall also consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee or registrant shall provide for vision correction, adequate communication, low temperature work environments and the concurrent use of other safety or radiological protection equipment. The licensee or registrant shall use equipment in such a way as not to interfere with the proper operation of the respirator.

24.1.6 Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

24.1.7 Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the Compressed Gas Association in publication G-7.1, "Commodity Specification for Air," 1997 and included in the regulations of the Occupational Safety and Health Administration (29 CFR 1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria include:

24.1.7.1 Oxygen content (v/v) of 19.5-23.5%;

24.1.7.2 Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less;

24.1.7.3 Carbon Monoxide (CO) content of 10 ppm or less;

24.1.7.4 Carbon Dioxide content of 1,000 ppm or less; and

24.1.7.5 Lack of noticeable odor.

24.1.8 The licensee shall ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face- facepiece seal or valve function, and that are under the control of the wearer, are present between the skin of the wearer’s face and the sealing surface of a tight- fitting respirator facepiece.

24.1.9 In estimating the dose to individuals from intake of airborne radioactive materials, the concentration of radioactive material in the air that is inhaled when respirators are worn is initially assumed to be the ambient concentration in air without the respiratory protection, divided by the assigned protection factor. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.

25.1 The Agency may impose restrictions in addition to the provisions of Sections 23.0 and 24.0, and Appendix A of this Part, in order to:

25.1.1 Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of radioactive materials consistent with maintaining total effective dose equivalent ALARA; and

25.1.2 Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

26.1 The licensee or registrant shall obtain authorization from the Agency before using assigned respiratory protection factors in excess of those specified in Appendix A. The Agency may authorize a licensee or registrant to use higher protection factors on receipt of an application that:

26.1.1 Describes the situation for which a need exists for higher protection factors; and

26.1.2 Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

Storage and Control of Licensed or Registered

Sources of Radiation

27.1 The licensee or registrant shall secure licensed or registered radioactive material from unauthorized removal or access.

27.2 The licensee or registrant shall maintain constant surveillance, and use engineering controls or devices, or administrative procedures to prevent unauthorized use of licensed or registered radioactive material that is in an unrestricted area and that is not in storage.

27.3 The registrant shall secure registered radiation machines from unauthorized removal.

27.4 The registrant shall use devices or administrative procedures to prevent unauthorized use of registered radiation machines.

Precautionary Procedures

28.1 Standard Radiation Symbol. Unless otherwise authorized by the Agency, the symbol prescribed by this section shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:

Figure 1. Radiation Symbol.

1. Cross-hatched area is to be magenta, or purple, or black, and

2. The background is to be yellow.

28.2 Exception to Color Requirements for Standard Radiation Symbol. Notwithstanding the requirements of subsection 28.1, licensees or registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.

28.3 Additional Information on Signs and Labels. In addition to the contents of signs and labels prescribed in Part D, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

29.1 Posting of Radiation Areas. The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."

29.2 Posting of High Radiation Areas. The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA."

29.3 Posting of Very High Radiation Areas. The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words " DANGER, VERY HIGH RADIATION AREA."

29.4 Posting of Airborne Radioactivity Areas. The licensee or registrant shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA."

29.5 Posting of Areas or Rooms in which Licensed or Registered Material is Used or Stored. The licensee or registrant shall post each area or room in which there is used or stored an amount of licensed or registered material exceeding 10 times the quantity of such material specified in Appendix C with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."

30.1 A licensee or registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than 8 hours, if each of the following conditions is met:

30.1.1 The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in Part D; and

30.1.2 The area or room is subject to the licensee’s or registrant’s control.

30.2 A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at 30 centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert (0.005 rem or 5 millirem) per hour.

30.3 A room or area is not required to be posted with a caution sign because of the presence of radiation machines used solely for diagnosis in the healing arts.

30.4 Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs under Section 29.0 if:

30.4.1 Access to the room is controlled pursuant to the providers ALARA license conditions; and

30.4.2 Personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this Part.

Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

32.1 A licensee or registrant is not required to label radiation machines if:

32.1.1 The area or room is subject to the licensee’s or registrant’s control and precautions are taken to prevent the exposure of individuals to sources of radiation in excess of the limits established in Part D.

Waste Disposal

Compliance with Environmental and Health Protection Regulations. Nothing in these regulations relieves the licensee or registrant from complying with other applicable Federal, State and local regulations governing any other toxic or hazardous properties of materials disposed of by the licensee or registrant.

Records

34.1 Each licensee or registrant shall use the Standard Internationale (SI) units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by Part D.

34.2 The licensee or registrant shall make a clear distinction among the quantities entered on the records required by Part D, such as, total effective dose equivalent shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

35.1 Each licensee or registrant shall maintain records of the radiation protection program, including:

35.1.1 The provisions of the program; and

35.1.2 Audits and other reviews of program content and implementation.

35.2 The licensee or registrant shall retain the records required by subsection 35.1.1 until the Agency terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain the records required by subsection 35.1.2 for 3 years after the record is made.

36.1 Each licensee or registrant shall maintain records showing the results of surveys and calibrations required by Section 16.0. The licensee or registrant shall retain these records for 3 years after the record is made.

36.2 The licensee or registrant shall retain each of the following records until the Agency terminates each pertinent license or registration requiring the record:

36.2.1 Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

36.2.2 Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

36.2.3 Records showing the results of air sampling, surveys, and bioassays required pursuant to subsections 24.1.3.1 and 24.1.3.2; and

36.2.4 Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

37.1 For each individual who is likely to receive, in a year, an occupational dose requiring monitoring pursuant to Section 17.0, the licensee or registrant shall:

37.1.1 Determine the occupational radiation dose received during the current year; and

37.1.2 Attempt to obtain the records of cumulative occupational radiation dose.

37.2 Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant shall determine:

37.2.1 The internal and external doses from all previous planned special exposures; and

37.2.2 All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual; and

37.3 In complying with the requirements of subsection 37.1, a licensee or registrant may:

37.3.1 Accept, as a record of the occupational dose that the individual received during the current year, a written signed statement from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual received during the current year; and

37.3.2 Accept, as the record of cumulative radiation dose, an up-to-date Agency Form Y (Part J, Appendix B) or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and.

37.3.3 Obtain reports of the individual's dose equivalent(s) from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, email, facsimile, other electronic media or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

37.4 The licensee or registrant shall record the exposure history, as required by subsection 37.1, on Agency Form Y, (Part J, Appendix B) or other clear and legible record, of all the information required on that form.

37.4.1 The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing Agency form Y (Part J, Appendix B) or equivalent. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on Agency Form Y or equivalent indicating the periods of time for which data are not available.

37.4.2 For the purposes of complying with this requirement, licensees or registrants are not required to partition historical dose between external dose equivalent(s) and internal committed dose equivalent(s). Further, occupational exposure histories obtained and recorded on Agency Form Y (Part J, Appendix B) or equivalent before July 10, 2002, would not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual.

37.5 If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

37.5.1 In establishing administrative controls pursuant to subsection 6.6 for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem, or 1250 millirem) for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

37.5.2 That the individual is not available for planned special exposures.

37.6 The licensee or registrant shall retain the records on Agency Form Y (Part J, Appendix B) or equivalent until the Agency terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing Agency Form Y (Part J, Appendix B) or equivalent for 3 years after the record is made.

37.7 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Agency Form Y (Part J, Appendix B) or equivalent, or shall make provision with the Agency for transfer to the Agency.

38.1 For each use of the provisions of Section 10.0 for planned special exposures, the licensee or registrant shall maintain records that describe:

38.1.1 The exceptional circumstances requiring the use of a planned special exposure;

38.1.2 The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

38.1.3 What actions were necessary;

38.1.4 Why the actions were necessary;

38.1.5 What precautions were taken to assure that doses were maintained ALARA;

38.1.6 What individual and collective doses were expected to result; and

38.1.7 The doses actually received in the planned special exposure.

38.2 The licensee or registrant shall retain the records until the Agency terminates each pertinent license or registration requiring these records.

38.3 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Agency Form Y (Part J, Appendix B) or equivalent, or shall make provision with the Agency for transfer to the Agency.

39.1 Recordkeeping Requirement. Each licensee or registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to Section 17.0, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before need not be changed. These records shall include, when applicable:

39.1.1 The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

39.1.2 The estimated intake of radionuclides, see Section 7.0;

39.1.3 The committed effective dose equivalent assigned to the intake of radionuclides;

39.1.4 The specific information used to calculate the committed effective dose equivalent pursuant to subsections 9.1 and 9.3 and when required by Section 17.0;

39.1.5 The total effective dose equivalent when required by Section 7.0; and

39.1.6 The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

39.2 Recordkeeping Frequency. The licensee or registrant shall make entries of the records specified in subsection 39.1 at intervals not to exceed 1 year.

39.3 Recordkeeping Format. The licensee or registrant shall maintain the records specified in subsection 39.1 on Agency Form Z (Part J, Appendix C), in accordance with the instructions for Agency Form Z (Part J, Appendix C), or in clear and legible records containing all the information required by Agency Form Z (Part J, Appendix C).

39.4 The licensee or registrant shall maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, shall also be kept on file, but must be maintained as confidential records, accessible only to the registrant or licensee Radiation Safety Officer, the declared pregnant woman, and medical personnel authorized to access her confidential health records.

39.5 The licensee or registrant shall retain each required form or record until the Agency terminates each pertinent license or registration requiring the record.

39.6 Upon termination of the license or registration, the licensee or registrant shall permanently store records on Agency Form Y (Part J, Appendix B) or equivalent, or shall make provision with the Agency for transfer to the Agency.

40.1 Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See Section 13.0.

40.2 The licensee or registrant shall retain the records required by subsection 40.1 until the Agency terminates each pertinent license or registration requiring the record.

Compliance with Environmental and Health Protection Regulations. Nothing in these regulations relieves the licensee or registrant from complying with other applicable Federal, State and local regulations governing any other toxic or hazardous properties of materials that may be disposed of by the licensee or registrant.

42.1 Each licensee or registrant shall maintain records of tests made pursuant to subsection 21.2.9 on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.

42.2 The licensee or registrant shall retain the records required by subsection 42.1 for 3 years after the record is made.

Each record required by Part D shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period or the record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

Records of tests for leakage or contamination of sealed sources required by Part D, Section 15.0 shall be kept on file in accordance with the facility radioactive material license.

Reports

45.1 Telephone Reports. Each licensee or registrant shall report to the Agency by telephone immediately after its occurrence becomes known to the registrant, any stolen, lost, or missing radiation machine.

45.2 Written Reports. Each licensee or registrant required to make a report pursuant to subsection 45.1 shall, within 30 days after making the telephone report, make a written report to the Agency setting forth the following information:

45.2.1 A description of the licensed or registered source of radiation involved, including, for radiation machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted;

45.2.2 A description of the circumstances under which the loss or theft occurred;

45.2.3 A statement of disposition, or probable disposition, of the registered source of radiation involved;

45.2.4 Exposures of individuals to radiation, and circumstances under which the exposures occurred;

45.2.5 Actions that have been taken, or will be taken, to recover the source of radiation; and

45.2.6 Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

45.3 Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.

45.4 The licensee or registrant shall prepare any report filed with the Agency pursuant to this section so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

46.1 Immediate Notification. Notwithstanding other requirements for notification, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

46.1.1 An individual to receive:

46.1.1.1 A total effective dose equivalent of 0.25 sievert (25 rem, or 25,000 millirem) or more;

46.1.1.2 A lense dose equivalent of 0.75 sievert (75 rem, or 75,000 millirem) or more; or

46.1.1.3 A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 gray (250 rad) or more; or

46.1.2 The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

46.2 Twenty-Four Hour Notification. Each licensee or registrant shall, within 24 hours of discovery of the event, report to the Agency each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following conditions:

46.2.1 An individual to receive, in a period of 24 hours:

46.2.1.1 A total effective dose equivalent exceeding 0.05 sievert (5 rem, or 5000 millirem);

46.2.1.2 A lense dose equivalent exceeding 0.15 sievert (15 rem, or 15,000 millirem);

46.2.1.3 A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (50 rem, or 50,000 millirem); or

46.2.2 The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

46.3 Licensees or registrants shall make the reports required by subsections 46.1 and 46.2 by initial contact by telephone to the Agency and shall confirm the initial contact immediately by email, express mail or facsimile to the Agency. The Agency shall reply to the written notification within 24 hours to discuss timing of follow-up action by the Agency.

46.4 The licensee or registrant shall prepare each report filed with the Agency pursuant to Section 46.0 so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

46.5 The provisions of Section 46.0 do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported pursuant to Section 48.0.

47.1 Reportable Events. In addition to the notification required by Section 46.0, each licensee or registrant shall submit a written report within 30 days after learning of any of the following occurrences:

47.1.1 Incidents for which notification is required by Section 46.0; or

47.1.2 Doses in excess of any of the following:

47.1.2.1 The occupational dose limits for adults in Section 6.0;

47.1.2.2 The occupational dose limits for a minor in Section 11.0;

47.1.2.3 The limits for an embryo/fetus of a declared pregnant woman in Section 12.0;

47.1.2.4 The limits for an individual member of the public in Section 13.0;

47.1.2.5 Any applicable limit in the license or registration; or

47.1.2.6 The ALARA constraints for air emissions established under subsection 5.4

47.1.3 Level of radiation or concentrations of radioactive material in:

47.1.3.1 A restricted area in excess of applicable limits in the license or registration; or

47.1.3.2 An unrestricted area in excess of 10 times the applicable limit set forth in Part D or in the license or registration, whether or not involving exposure of any individual in excess of the limits in Section 13.0; or

47.1.4 For licensees subject to the provisions of the Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

47.2 Contents of Reports.

47.2.1 Each report required by subsection 47.1 shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

47.2.1.1 Estimates of each individual's dose;

47.2.1.2 The levels of radiation and concentrations of radioactive material involved;

47.2.1.3 The cause of the elevated exposures, dose rates, or concentrations; and

47.2.1.4 Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints generally applicable environmental standards, and associated license or registration conditions.

47.2.2 Each report filed pursuant to subsection 47.1 shall include for each occupationally overexposeda/ individual: the name, unique identification number such as employee or Social Security number, and date of birth. With respect to the limit for the embryo/fetus in Section 12.0, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.

47.3 All licensees or registrants who make reports pursuant to subsection 47.1 shall submit the report in writing to the Agency.

The licensee or registrant shall submit a written report to the Agency within 30 days following any planned special exposure conducted in accordance with Section 10.0, informing the Agency that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by Part D, Section 38.0.

When a licensee or registrant is required, pursuant to Part D, Sections 47.0, 48.0, or D.2206 22.6 to report to the Agency any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee shall also provide a copy of the report submitted to the Agency to the individual. This report must be transmitted at a time no later than the transmittal to the Agency.

50.1 Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in Part J, Section 4.0 of these regulations.

50.2 When a licensee or registrant is required pursuant to Section 47.0 to report to the Agency any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual. Such notice shall be transmitted at a time not later than the transmittal to the Agency, and shall comply with the provisions of Part J, Subsection 4.1 of these regulations.

Additional Requirements

Each specific licensee or registrant in possession of a radiation source shall, no less than 30 days before vacating or relinquishing possession or control of premises, notify the Agency in writing of intent to vacate. When deemed necessary by the Agency, the licensee shall decontaminate the premises in such a manner as the Agency may specify.

A PDF version of Appendices A-F for Part D is available here:

http://regulations.delaware.gov/AdminCode/title16/Department of Health and Social Services/Division of Public Health/Health Systems Protection (HSP)/4465 PART D APPENDICES A-F.pdf

This Part establishes requirements, for which a registrant is responsible, for use of diagnostic x-ray equipment by, or under the supervision of, an individual authorized by and licensed in accordance with State statutes to engage in the healing arts or veterinary medicine. The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of Parts A, B, D, J and K of the regulations. Some registrants may also be subject to the requirements of Parts I and X of the regulations.

As used in this Part, the following definitions apply:

"Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer.

"Accessory component" means:

(1) A component used with diagnostic x-ray systems, such as a cradle or film changer, that is not necessary for the compliance of the system with applicable provisions of this Part but which requires an initial determination of compatibility with the system; or

(2) A component necessary for compliance of the system with applicable provisions of this Part but which may be interchanged with similar compatible components without affecting the system’s compliance, such as one of a set of interchangeable beam-limiting devices; or

(3) A component compatible with all x-ray systems with which it may be used and that does not require compatibility or installation instructions, such as a tabletop cassette holder.

"Air kerma" means kerma in air (see definition of Kerma).

"Air kerma rate (AKR)" means the air kerma per unit time.

"Aluminum equivalent" means the thickness of type 1100 aluminum alloy (The nominal chemical composition of type 1100 aluminum is 99.00 percent minimum aluminum, 0.12 percent copper.) affording the same attenuation, under specified conditions, as the material in question.

"Articulated joint" means a joint between two separate sections of a tabletop which joint provides the capacity of one of the sections to pivot on the line segment along which the sections join.

"Assembler" means any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray system or his or her employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services.

"Attenuation block" means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy (The nominal chemical composition of type 1100 aluminum is 99.00 percent minimum aluminum, 0.12 percent copper.) or other materials having equivalent attenuation.

"Automatic exposure control (AEC)" means a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation (Includes devices such as phototimers and ion chambers).

"Automatic exposure rate control (AERC)" means a device which automatically controls one or more technique factors in order to obtain, at a preselected location(s), a required quantity of radiation per unit time.

"Barrier" (See "Protective barrier").

"Beam axis" means a line from the source through the centers of the x-ray fields.

"Beam-limiting device" means a device which provides a means to restrict the dimensions of the x- ray field.

"Bone densitometry system" means a medical device which uses electronically-produced ionizing radiation to determine the density of bone structures of human patients.

"C-arm fluoroscope" means a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.

"Cantilevered tabletop" means a tabletop designed such that the unsupported portion can be extended at least 100 cm beyond the support.

"Cassette holder" means a device, other than a spot-film device, that supports and/or fixes the position of an x-ray film [imaging] cassette during an x-ray exposure.

"Coefficient of variation (C)" means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

where:

n = Number of observations sampled.

"Computed tomography (CT)" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.

"Control panel" means that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.

"Cooling curve" means the graphical relationship between heat units stored and cooling time.

"Cradle" means:

(1) A removable device which supports and may restrain a patient above an x-ray table; or

(2) A device;

(i) Whose patient support structure is interposed between the patient and the image receptor during normal use;

(ii) Which is equipped with means for patient restraint; and

(iii) Which is capable of rotation about its long (longitudinal) axis.

"CT" (See "Computed tomography").

"CT gantry" means tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold and/or enclose these components.

"Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.

"Detector" (See "Radiation detector")

"Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.

"Diagnostic x-ray system" means an x-ray system designed for irradiation of any part of the human [or animal] body for the purpose of diagnosis or visualization.

"Direct scattered radiation" means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").

"Dose" means the absorbed dose as defined by the International Commission on Radiation Units and Measurements. The absorbed dose, D, is the quotient of de by dm, where de is the mean energy imparted to matter of mass dm; thus D=de/dm, in units of J/kg, where the special name of the unit of absorbed dose is gray (Gy).

"Equipment" (See "X-ray equipment").

"Exposure (X)" means the quotient of dQ by dm where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated or created by photons in air of mass dm are completely stopped in air; thus X=dQ/dm, in units of C/kg. A second meaning of exposure is the process or condition during which the x-ray tube produces x-ray radiation.

"Field emission equipment" means equipment which uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

"Filter" means material placed in the useful beam to preferentially absorb selected radiations.

"Fluoroscopic air kerma display devices" means separate devices, subsystems, or components that provide the display of AKR and cumulative air kerma, respectively, required by 5.0. They include radiation detectors, if any, electronic and computer components, associated software, and data displays.

"Fluoroscopic imaging assembly" means a subsystem in which x-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

"Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation.

"Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term “radioscopy” in the standards of the International Electrotechnical Commission.

"Focal spot (actual)" means the area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

"General purpose radiographic x-ray system" means any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.

"Gonad shield" means a protective barrier for the testes or ovaries.

"Half-value layer (HVL)" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.

"Hand-held x-ray equipment" means x-ray equipment that is designed to be hand-held during operation.

"Healing arts screening" means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.

"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, i.e., kVp x mA x second.

"HVL" (See "Half-value layer").

"Image intensifier" means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.

"Image receptor" means any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term “image receptor” shall mean the preselected portion of the device.

"Image receptor support device" means, for mammography x-ray systems, that part of the system designed to support the image receptor during a mammographic examination and to provide a primary protective barrier.

"Irradiation" means the exposure of matter to ionizing radiation.

"Isocenter" means the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center.

"Kerma" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma, K, is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all the charged participles liberated by uncharged particles in a mass dm of material; thus K=dEtr/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as “air kerma.”

"Kilovolts peak" (See "Peak tube potential").

"kV" means kilovolts.

"kVp" (See "Peak tube potential").

"kWs" means kilowatt second.

"Last image hold (LIH) radiograph" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

"Lateral fluoroscope" means the x-ray tube and image receptor combination in a biplane system dedicated to the lateral projection. It consists of the lateral x-ray tube housing assembly and the lateral image receptor that are fixed in position relative to the table with the x-ray beam axis parallel to the plane of the table.

"Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

"Leakage radiation" means radiation emanating from the diagnostic source assembly except for:

(1) The useful beam; and

(2) Radiation produced when the exposure switch or timer is not activated.

"Leakage technique factors" means the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows:

(1) For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs (or 10 mAs) or the minimum obtainable from the unit, whichever is larger;

(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential;

(3) For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

"Licensed Practitioner" means an individual licensed to practice medicine, dentistry, dental hygiene, podiatry, chiropractic, or osteopathy in this State.

"Light field" means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.

"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percent of the load line potential , as follows:

Percent line-voltage regulation = 100 (Vn-Vl)/Vl

where:

Vn = No-load line potential; and

Vl = Load line potential.

"mA" means milliampere.

“mAs" means milliampere second.

"Mobile x-ray equipment" (See "X-ray equipment").

"Mode of operation" means, for fluoroscopic systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.

"Movable tabletop" means a tabletop which, when assembled for use, is capable of movement with respect to its supporting structure within the plane of the tabletop.

"Non-image-intensified fluoroscopy" means fluoroscopy using only a fluorescent screen.

"Patient" means an individual or animal subjected to healing arts examination, diagnosis or treatment.

"PBL" See "Positive beam limitation."

"Peak tube potential" means the maximum value of the potential difference across the x-ray tube during an exposure.

"Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.

"PID" (See "Position indicating device").

"Portable x-ray equipment" (See "X-ray equipment").

"Position indicating device" means a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

"Positive beam limitation" means the automatic or semi-automatic adjustment of an x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.

"Primary protective barrier" means the material, excluding filters, placed in the useful beam to reduce the radiation exposure [beyond the patient and cassette holder] for protection purposes.

"Protective apron" means an apron made of radiation absorbing materials used to reduce radiation exposure.

"Protective glove" means a glove made of radiation absorbing materials used to reduce radiation exposure.

"Pulsed mode" means operation of the x-ray system such that the x-ray tube current is pulsed by the x-ray control to produce one or more exposure intervals of duration less than one-half second.

“Qualified expert” means an individual who has demonstrated to the satisfaction of the Agency that such individual possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with Part X.

"Qualified medical physicist" means an individual who meets the requirements specified in Part X.

"Quick change x-ray tube" means an x-ray tube designed for use in its associated tube housing such that:

(1) The tube cannot be inserted in its housing in a manner that would result in noncompliance of the system with the requirements of 6.0;

(2) The focal spot position will not cause noncompliance with the provisions of this section or;

(3) The shielding within the tube housing cannot be displaced; and

(4) Any removal and subsequent replacement of a beam-limiting device during reloading of the tube in the tube housing will not result in noncompliance of the x-ray system with the applicable field limitation and alignment requirements of 6.0.

"Radiation detector" means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation.

"Radiation therapy simulation system" means a radiographic or fluoroscopic x‑ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

"Radiograph" means an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.

"Radiography" means a technique for generating and recording an x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.

"Rated line voltage" means the range of potentials, in volts, of the supply line specified by the manufacturer at which the x-ray machine is designed to operate.

"Rated output current" means the maximum allowable load current of the x-ray high-voltage generator.

"Rating" means the operating limits specified by the manufacturer.

"Recording" means producing a retrievable form of an image resulting from x-ray photons.

"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data may be collected simultaneously during a single scan for the production of one or more tomograms.

"Scan time" means the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.

"Scattered radiation" means radiation that, during passage through matter, has been deviated in direction (See "Direct scattered radiation").

"Shutter" means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

"SID" (See "Source-image receptor distance").

"Solid state x-ray imaging device" means an assembly, typically in a rectangular panel configuration, that intercepts x-ray photons and converts the photon energy into a modulated electronic signal representative of the x-ray intensity over the area of the imaging device. The electronic signal is then used to create an image for display and/or storage.

"Source" means the focal spot of the x-ray tube.

"Source-image receptor distance" means the distance from the source to the center of the input surface of the image receptor.

"Source-skin distance (SSD)" means the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient skin surface.

"Spot film" means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.

"Spot-film device" means a device intended to transport and/or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of the fluoroscopic image receptor for the purpose of producing a radiograph.

"Stationary tabletop" means a tabletop which, when assembled for use, is incapable of movement with respect to its supporting structure within the plane of the tabletop.

"Stationary x-ray equipment" (See "X-ray equipment").

"Stray radiation" means the sum of leakage and scattered radiation.

"Technique factors" means the following conditions of operation:

(1) For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);

(2) For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of x-ray pulses;

(3) For CT equipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;

(4) For CT equipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and

(5) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs.

"Tomogram" means the depiction of the x-ray attenuation properties of a section through the body.

"Tube" means an x-ray tube, unless otherwise specified.

"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

"Tube rating chart" means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.

"Useful beam" means the radiation which passes through the tube housing port and the aperture of the beam limiting device when the exposure switch or timer is activated.

"Variable-aperture beam-limiting device" means a beam-limiting device which has capacity for stepless adjustment of the x-ray field size at a given SID.

"Visible area" means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

"X-ray control" means a device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an x-ray exposure.

"X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The x-ray exposure control may include such associated equipment as timers and back-up timers.

"X-ray equipment" means an x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows:

(1) "Mobile x-ray equipment" means x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled.

(2) "Portable x-ray equipment" means x-ray equipment designed to be hand-carried.

(3) "Stationary x-ray equipment" means x-ray equipment which is installed in a fixed location.

"X-ray field" means that area of the intersection of the useful beam and any one of a set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR is one-fourth of the maximum in the intersection.

"X-ray high-voltage generator" means a device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for trans­forming alternating current to direct current, filament transformers for the x-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.

"X-ray subsystem" means any combination of two or more components of an x-ray system for which there are requirements specified in this section and 4.0, 5.0, 6.0.

"X-ray system" means an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.

"X-ray table" means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography and/or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film device beneath the tabletop.

"X-ray tube" means any electron tube which is designed for the conversion of electrical energy into x-ray energy.

3.1 Radiation Safety Requirements. The registrant, licensee, shall be responsible for directing the operation of the x-ray system(s) under his administrative control. The registrant, licensee, or the registrant's, licensee’s, agent shall assure that the requirements of these regulations are met in the operation of the x-ray system(s).

3.1.1 An x-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic purposes.

3.1.2 Individuals who will be operating the x-ray systems shall meet the Agency’s qualifications to conduct the practice of radiologic technology.

3.1.3 A chart shall be provided in the vicinity of the diagnostic x-ray system's control panel which specifies, for all examinations performed with that system, the following information:

3.1.3.1 Patient's body part and anatomical size, or body part thickness, or age (for pediatrics), versus technique factors to be utilized;

3.1.3.2 Type and size of the image receptor to be used;

3.1.3.3 Type and size of the image receptor combination to be used, if any;

3.1.3.4 Source to image receptor distance to be used (except for dental intraoral radiography);

3.1.3.5 Type and location of placement of patient shielding (e.g., gonad, etc.) to be used; and

3.1.3.6 For mammography, indication of kVp/target/filter combination.

3.1.4 The registrant [licensee] of a facility shall create and make available to x-ray operators written safety procedures, including patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.

3.1.5 Except for patients who cannot be moved out of the room, only the staff, ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:

3.1.5.1 All individuals shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent material;

3.1.5.2 The x-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent material;

3.1.5.3 Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or shall be so positioned that the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.

3.1.6 Gonad shielding of not less than 0.5 millimeter lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.

3.1.7 Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

3.1.7.1 Exposure of an individual for training, demonstration, or other non-healing arts purposes; and

3.1.7.2 Exposure of an individual for the purpose of healing arts screening except as authorized by 3.1.11.

3.1.8 When a patient or image receptor must be provided with auxiliary support during a radiation exposure:

3.1.8.1 Mechanical holding devices shall be used when the technique permits. The written safety procedures, required by 3.1.4, shall list individual projections where holding devices cannot be utilized;

3.1.8.2 Written safety procedures, as required by 3.1.4, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

3.1.8.3 The human holder shall be instructed in personal radiation safety and protected as required by 3.1.5.;

3.1.8.4 No individual shall be used routinely to hold image receptor or patients;

3.1.8.5 In those cases where the patient must hold the image receptor, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material; and

3.1.8.6 Each facility shall have leaded aprons and gloves available in sufficient numbers to provide protection for all personnel who are involved with x-ray operations and who are otherwise not shielded.

3.1.9 Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized.

3.1.9.1 The fastest imaging system consistent with the diagnostic objective of the examinations shall be used. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intraoral use in dental radiography.

3.1.9.2 The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.

3.1.9.3 Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary x-ray installation. The use of hand held devices must be approved by the Agency utilizing the criteria in Appendix B.

3.1.9.4 X-ray systems subject to 6.0 shall not be utilized in procedures where the source to patient distance is less than 30 centimeters, except for veterinary systems.

3.1.9.5 If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall:

3.1.9.5.1 Be positioned properly, i.e., tube side facing the right direction, and grid centered to the central ray;

3.1.9.5.2 If the grid is of the focused type, be of the proper focal distance for the SIDs being used.

3.1.10 All individuals who are associated with the operation of an x-ray system are subject to the requirements of D.1201, D.1207 and D.1208 of these regulations.

3.1.11 Healing Arts Screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Agency. When requesting such approval, that person shall submit the information outlined in Appendix A of this Part. If any information submitted to the Agency becomes invalid or outdated, the Agency shall be immediately notified.

3.1.12 Information and Maintenance Record and Associated Information. The registrant [licensee] shall maintain the following information for each x-ray system for inspection by the Agency:

3.1.12.1 Model and serial numbers of all major components, and user's manuals for those components;

3.1.12.2 Tube rating charts and cooling curves;

3.1.12.3 Records of surveys, calibrations, maintenance, and modifications performed on the x-ray system(s); and

3.1.12.4 A copy of all correspondence with this Agency regarding that x-ray system.

3.1.13 X-Ray Utilization Record. Except for veterinary facilities, each facility shall maintain a record containing the patient's name, the type of examinations, and the dates the examinations were performed. When the patient or film must be provided with human auxiliary support, the name of the human holder should be recorded.

3.2 X-Ray Film Processing Facilities and Practices.

3.2.1 Each installation using a radiographic x-ray system and using analog image receptors (e.g. radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

3.2.1.1 Manually developed film:

3.2.1.2 Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and

3.2.1.3 The temperature of solutions in the tanks shall be maintained within the range of 60o F to 80o F (16o C to 27o C). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the following time-temperature chart:

3.2.1.4 Devices shall be utilized which will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required.

3.2.1.5 Automatic processors and other closed processing systems: Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film shall be developed using the following chart:

3.2.1.6 Processing deviations from the requirements of 3.2.1 shall be documented by the registrant [licensee] in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry).

3.3 Other Requirements.

3.3.1 Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

3.3.2 The darkroom shall be light tight and use proper safelighting such that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density from 1 to 2 when processed shall not suffer an increase in density greater than 0.1 (0.05 for mammography) when exposed in the darkroom for 2 minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

3.3.3 Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

3.3.4 Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.

3.3.5 Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary to best assure radiographs of good diagnostic quality.

3.3.6 Outdated x-ray film shall not be used for diagnostic radiographs, unless the film has been stored in accordance with the manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.

3.3.7 Film developing solutions shall be prepared in accordance with the directions given by the manufacturer, and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.

In addition to other requirements of this Part, all diagnostic x‑ray systems shall meet the following requirements:

4.1 Warning Label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."

4.2 Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (vice 100 milliroentgen (mR) exposure) in 1 hour when the x-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

4.3 Radiation from Components Other Than the Diagnostic Source Assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (vice 2 milliroentgens exposure) in 1 hour at 5 centimeters from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

4.4 Beam Quality.

4.4.1 Half-Value Layer (HVL).

4.4.1.1 The HVL of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 1 in this section under the heading “Specified Dental Systems,” for any dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980; under the heading, “I-Other X-Ray Systems,” for any dental x-ray system designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006; and under the heading, “II-Other X-Ray Systems,” for all x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table 1 of this section, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent x-ray emissions if the minimum required filtration is not in place.

4.4.1.2 Optional filtration. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube(s) with a continuous output of 1 kilowatt or more and an anode heat storage capacity of 1 million heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions of this subsection. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.

4.4.1.3 Measuring compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.

4.4.1.4 Aluminum equivalent of material between patient and image receptor. Except when used in a CT x-ray system, the aluminum equivalent of each of the items listed in Table 2 in this paragraph, which are used between the patient and the image receptor, may not exceed the indicated limits. Compliance shall be determined by x-ray measurements made at a potential of 100 kilovolts peak and with an x-ray beam that has an HVL specified in Table 1 of this section for the potential. This requirement applies to front panel(s) of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids. Table 2 follows:

4.5 Battery charge indicator. On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

4.6 Modification of certified diagnostic x-ray components and systems.

4.7 Diagnostic x-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this Part.

4.8 The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this Part. The owner who causes such modification need not submit the reports required by this Part, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with this Part. Such system modifications should be per suggested manufacturer’s specifications.

4.9 Multiple Tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.

4.10 Mechanical Support of Tube Head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.

4.11 Technique Indicators.

4.11.1 For x-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.

4.11.2 The requirement of 4.11.1 may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

4.12 Maintaining Compliance. Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.

4.13 Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.

The provisions of this Part apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.

5.1 Primary Protective Barrier.

5.1.1 Limitation of useful beam. The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34x10-3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation.

5.1.2 Measuring compliance. The AKR shall be measured in accordance with 5.3.2. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm. Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.

5.2 Field Limitation.

5.2.1 Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with 5.2.4 and 5.2.5 shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

5.2.2 Further means for limitation. Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of 5.2.4 and 5.2.5. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or capability of a visible area of greater than 300 square cm, shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 square cm shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to 125 square cm or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of 5 cm by 5 cm. This paragraph does not apply to non-image-intensified fluoroscopy.

5.2.3 Non-image-intensified fluoroscopy. The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. Means shall be provided for stepless adjustment of field size. The minimum field size, at the greatest SID, shall be containable in a square of 5 cm by 5 cm.

5.2.4 Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.

5.2.4.1 For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:

5.2.4.1.1 Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID.

5.2.4.1.2 For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

5.2.4.2 For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one of the following requirements:

5.2.4.2.1 When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 cm in any direction, at least 80 percent of the area of the x-ray field overlaps the visible area of the image receptor, or

5.2.4.2.2 When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 cm in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than 2 cm.

5.2.5 Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies:

5.2.5.1 Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID.

5.2.5.2 The error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

5.3 If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist’s position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:

FOR X-RAY FIELD LIMITATION SYSTEM FAILURE

5.3.1 Activation of Tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.

5.3.2 Air Kerma Rates. For fluoroscopic equipment, the following requirements apply:

5.4 Fluoroscopic equipment manufactured before May 19, 1995.

5.4.1 Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in 5.6, except as specified in 5.4.4.1.

5.4.2 Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in 5.6, except as specified in 5.4.4.1.

5.4.3 Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) in either mode at the measurement point specified in 5.6, except as specified in 5.4.4.1.

5.4.4 Equipment may be modified in accordance with this Part to comply with 5.5. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

5.4.4.1 Exceptions:

5.4.4.1.1 During recording of fluoroscopic images, or

5.4.4.1.2 When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of the rates specified in paragraphs (1), (2) and (3) at the measurement point specified in 5.6, unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.

5.5 Fluoroscopic equipment manufactured on or after May 19, 1995.

5.5.1 Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in 5.6. Provision for manual selection of technique factors may be provided.

5.5.2 Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in 5.6, except as specified in 5.5.3.

5.5.3 Exceptions:

5.5.3.1 For equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode.

5.5.3.2 For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.

5.5.3.3 When a mode of operation has an optional high-level control and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure rate) at the measurement point specified in 5.6. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is employed.

5.6 Measuring compliance. Compliance with this subsection shall be determined as follows:

5.6.1 If the source is below the x-ray table, the AKR shall be measured at 1 cm above the tabletop or cradle.

5.6.2 If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

5.6.3 In a C-arm type of fluoroscope, the AKR shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly.

5.6.4 In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.

5.6.5 In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table.

5.7 Exemptions. Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in this subsection when used for therapy simulation purposes.

5.8 Reserved.

5.9 Indication of potential and current. During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer.

5.10 Source-skin distance.

5.10.1 Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operating at shorter source-skin distances but in no case less than 20 cm.

5.10.2 For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distance specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm.

5.11 Fluoroscopic irradiation time, display, and signal.

5.11.1 Fluoroscopic equipment manufactured before June 10, 2006:

5.11.1.1 Shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 CFR 1020.30(q) to comply with the requirements of this paragraph. When the equipment is modified, it shall bear a label indicating the statement:

5.12 Modified to comply with 21 CFR 1020.32(h)(2)

5.12.1 As an alternative to the requirements of this paragraph, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.

5.13 For x-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:

5.13.1 A display of the fluoroscopic irradiation time at the fluoroscopist’s working position. This display shall function independently of the audible signal described in this subsection. The following requirements apply:

5.13.1.1 When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every 6 seconds.

5.13.1.2 The fluoroscopic irradiation time shall also be displayed within 6 seconds of termination of an exposure and remain displayed until reset.

5.13.1.3 Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure.

5.13.2 A signal audible to the fluoroscopist shall sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least 2 seconds.

5.14 Mobile and portable fluoroscopes. In addition to the other requirements of this subsection, mobile and portable fluoroscopes shall provide an image receptor incorporating more than a simple fluorescent screen.

5.15 Display of last-image-hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.

5.16 For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure.

5.17 For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.

5.18 Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.

5.19 Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist’s working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:

5.20 When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.

5.21 The cumulative air kerma in units of mGy shall be displayed either within 5 seconds of termination of an exposure or displayed continuously and updated at least once every 5 seconds.

5.22 The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.

5.23 The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope.

5.23.1 For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference location shall be the respective locations specified in 5.6.1, 5.6.2 or 5.6.5.

5.23.2 For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient’s skin.

5.24 Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.

5.25 The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ±35 percent over the range of 6 mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than 3 seconds.

5.26 Control of Scattered Radiation.

5.26.1 Fluoroscopic table designs when combined with procedures utilized shall be such that no unprotected part of any staff or ancillary individual's body shall be exposed to unattenuated scattered radiation which originates from under the table. The attenuation required shall be not less than 0.25 millimeter lead equivalent.

5.26.2 Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary individual's body, except the extremities, shall be exposed to the unattenuated scattered radiation emanating from above the tabletop unless that individual:

5.26.2.1 Is at least 120 centimeters from the center of the useful beam; or

5.26.2.2 The radiation has passed through not less than 0.25 millimeter lead equivalent material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in 3.1.5.2.

5.27 The Agency may grant exemptions to 5.26.2. where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the Agency shall not permit such exemption. See Appendix C for a suggested list of fluoroscopic procedures where such exemptions will be automatically granted.

5.28 Operator Qualifications.

5.28.1 The facility shall ensure that only a licensed practitioner of the healing arts or a radiologic technologist be allowed to operate fluoroscopic x-ray systems. A licensed practitioner includes any health practitioner of the healing Arts who is licensed in the state to diagnose and treat individuals and who operates within the scope defined in the state law. This includes physicians and physician assistants and excludes nurse practitioners.

5.28.2 All persons operating fluoroscopic x-ray systems shall have completed at least the following training before using fluoroscopy independently: 5.28.1.

5.28.2.1 Biological effects of x-ray;

5.28.2.2 Principles of radiation protection;

5.28.2.3 Factors affecting fluoroscopic outputs;

5.28.2.4 Dose reduction techniques for fluoroscopic x-ray systems;

5.28.2.5 Principles and operation of the specific fluoroscopic x-ray system(s) to be used;

5.28.2.6 Fluoroscopic and fluorographic outputs of each mode of operation on the system(s) to be used clinically; and

5.28.2.7 Applicable requirements of these regulations.

5.29 The facility shall either provide annual in-service training for all operators of fluoroscopic x-ray systems used for high dose, high risk procedures, or require evidence of annual continuing medical education in fluoroscopic radiation safety and patient dose management.

5.30 Documentation pertaining to the requirements of 5.28.2 and 5.29, shall be maintained for review for three years.

5.31 Equipment Operation.

5.31.1 All imaging formed by the use of fluoroscopic x-ray systems shall be viewed, directly or indirectly, and interpreted by a licensed practitioner of the healing arts.

5.31.2 The operation of fluoroscopic x-ray systems by radiologic technologists [or equivalent] shall be performed under the direct supervision of a licensed practitioner of the healing arts who meets the requirements of 5.28.

5.31.3 Radiologic technology students shall not be allowed to operate fluoroscopic x-ray systems unless directly supervised by a licensed practitioner of the healing arts or radiologic technologist as specified in 5.28.1.

5.31.4 Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

5.31.5 Facilities shall maintain a record of the cumulative fluoroscopic exposure time used and the number of fluorographic images recorded for each examination. This record shall include patient identification, type and date of examination, the fluoroscopic system used, and operator's name.

6.1 Control and indication of technique factors.

6.1.1 Visual indication. The technique factors to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls are used, in which case the technique factors which are set prior to the exposure shall be indicated. On equipment having fixed technique factors, this requirement may be met by permanent markings. Indication of technique factors shall be visible from the operator’s position except in the case of spot films made by the fluoroscopist.

6.1.2 Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.

6.1.2.1 Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero. It shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.

6.1.2.2 During serial radiography, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.

6.2 Automatic exposure controls. When an automatic exposure control is provided:

6.2.1 Indication shall be made on the control panel when this mode of operation is selected;

6.2.2 When the x-ray tube potential is equal to or greater than 51 kilovolts peak (kVp), the minimum exposure time for field emission equipment rated for pulse operation shall be equal to or less than a time interval equivalent to two pulses and the minimum exposure time for all other equipment shall be equal to or less than 1/60 second or a time interval required to deliver 5 milliampere-seconds (mAs), whichever is greater;

6.2.3 Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 kilowatt-seconds (kWs) per exposure or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure, except when the x-ray tube potential is less than 51 kVp, in which case the product of x-ray tube current and exposure time shall be limited to not more than 2,000 mAs per exposure; and

6.2.4 A visible signal shall indicate when an exposure has been terminated at the limits described in 6.2.3, and manual resetting shall be required before further automatically timed exposures can be made.

6.2.5 Accuracy. Deviation of technique factors from indicated values shall not exceed the limits given by the manufacturer.

6.2.5.1 Reproducibility. The following requirements shall apply when the equipment is operated on an adequate power supply as specified by the manufacturer:

6.2 Coefficient of variation. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than 0.05.

6.3 Measuring compliance. Determination of compliance shall be based on 10 consecutive measurements taken within a time period of 1 hour. Equipment manufactured after September 5, 1978, shall be subject to the additional requirement that all variable controls for technique factors shall be adjusted to alternate settings and reset to the test setting after each measurement. The percent line-voltage regulation shall be within ±1 of the mean value for all measurements. For equipment having automatic exposure controls, compliance shall be determined with a sufficient thickness of attenuating material in the useful beam such that the technique factors can be adjusted to provide individual exposures of a minimum of 12 pulses on field emission equipment rated for pulsed operation or no less than one-tenth second per exposure on all other equipment.

6.4 Linearity. The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer in accordance with 21 CFR Part 1020 for any fixed x-ray tube potential within the range of 40 percent to 100 percent of the maximum rated.

6.4.1 Equipment having independent selection of x-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum. This is: ׀X1 – X2׀ ≤ 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.

6.4.2 Equipment having selection of x-ray tube current-exposure time product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum. This is: ׀X1 – X2׀ ≤ 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.

6.4.3 Measuring compliance. Determination of compliance will be based on 10 exposures, made within 1 hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 mm and the other is greater than 0.45 mm. For purposes of this requirement, focal spot size is the focal spot size specified by the x-ray tube manufacturer. The percent line-voltage regulation shall be determined for each measurement. All values for percent line-voltage regulation at any one combination of technique factors shall be within ±1 of the mean value for all measurements at these technique factors.

6.5 Field limitation and alignment for mobile, portable, and stationary general purpose x-ray systems. Except when spot-film devices are in service, mobile, portable, and stationary general purpose radiographic x-ray systems shall meet the following requirements:

6.6 Variable x-ray field limitation. A means for stepless adjustment of the size of the x-ray field shall be provided. Each dimension of the minimum field size at an SID of 100 cm shall be equal to or less than 5 cm.

6.6.1 Visual definition.

6.6.1.1 Means for visually defining the perimeter of the x-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed 2 percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.

6.6.1.2 When a light localizer is used to define the x-ray field, it shall provide an average illuminance of not less than 160 lux (15 footcandles) at 100 cm or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement.

6.6.1.3 The edge of the light field at 100 cm or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than 4 in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than 3 in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I1/I2, where I1 is the illuminance 3 mm from the edge of the light field toward the center of the field; and I2 is the illuminance 3 mm from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring aperture of 1 mm.

6.7 Field indication and alignment on stationary general purpose x-ray equipment. Except when spot-film devices are in service, stationary general purpose x-ray systems shall meet the following requirements in addition to those prescribed in 6.5.

6.7.1 Means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within 2 percent of the SID, and to indicate the SID to within 2 percent;

6.7.2 The beam-limiting device shall numerically indicate the field size in the plane of the image receptor to which it is adjusted;

6.7.3 Indication of field size dimensions and SIDs shall be specified in centimeters and/or inches and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within 2 percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and

6.7.4 Compliance measurements will be made at discrete SIDs and image receptor dimensions in common clinical use (such as SIDs of 100, 150, and 200 cm and/or 36, 40, 48, 72 inches and nominal image receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 cm and/or 5, 7, 8, 9, 10, 11, 12, 14, and 17 inches) or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate.

6.8 Field limitation on radiographic x-ray equipment other than general purpose radiographic systems.

6.8.1 Equipment for use with intraoral image receptors. Radiographic equipment designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:

6.8.1.1 If the minimum source-to-skin distance (SSD) is 18 cm or more, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than 7 cm; and

6.8.1.2 If the minimum SSD is less than 18 cm, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than 6 cm.

6.9 X-ray systems designed for one image receptor size. Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of image receptor to within 2 percent of the SID, or shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond the edge of the image receptor.

6.10 Systems designed for mammography.

6.10.1 Radiographic systems designed only for mammography and general purpose radiography systems, when special attachments for mammography are in service, manufactured on or after November 1, 1977, and before September 30, 1999, shall be provided with means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor at any designated SID except the edge of the image receptor designed to be adjacent to the chest wall where the x-ray field may not extend beyond this edge by more than 2 percent of the SID. This requirement can be met with a system that performs as prescribed in 6.11.When the beam-limiting device and image receptor support device are designed to be used to immobilize the breast during a mammographic procedure and the SID may vary, the SID indication specified in 6.11 shall be the maximum SID for which the beam-limiting device or aperture is designed.

6.10.2 Mammographic beam-limiting devices manufactured on or after September 30, 1999, shall be provided with a means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor by more than 2 percent of the SID. This requirement can be met with a system that performs as prescribed in 6.11.For systems that allow changes in SID, the SID indication specified in 6.11 shall be the maximum SID for which the beam-limiting deviced or aperture is designed.

6.10.3 Each image receptor support device manufactured on or after November 1, 1977, intended for installation on a system designed for mammography shall have clear and permanent markings to indicate the maximum image receptor size for which it is designed.

6.11 Other x-ray systems. Radiographic systems not specifically covered in 6.5, 6.7, 6.8.1.2, 6.10, 6.18, and systems covered in 6.8.1, which are also designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2 percent of the SID, when the axis of the x-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the x-ray field with the center of the image receptor to within 2 percent of the SID, or means shall be provided to both size and alignment the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:

6.11.1 A system which performs in accordance with 6.5 and 6.7; or when alignment means are also provided, may be met with either;

6.11.2 An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or

6.11.3 A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

6.12 Positive beam limitation (PBL). The requirements of this subsection shall apply to radiographic systems which contain PBL.

6.12.1 Field size. When a PBL system is provided, it shall prevent x-ray production when:

6.12.1.1 Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than 3 percent of the SID; or

6.12.1.2 The sum of the length and width differences stated in 6.12.1.1 without regard to sign exceeds 4 percent of the SID.

6.13.1.3 The beam-limiting device is at an SID for which PBL is not designed for sizing.

6.13 Conditions for PBL. When provided, the PBL system shall function as described in 6.12.1 whenever all the following conditions are met:

6.13.1 The image receptor is inserted into a permanently mounted cassette holder;

6.13.2 The image receptor length and width are less than 50 cm;

6.13.3 The x-ray beam axis is within ±3 degrees of vertical and the SID is 90 cm to 130 cm inclusive; or the x-ray beam axis is within ±3 degrees of horizontal and the SID is 90 cm to 205 cm inclusive;

6.13.4 The x-ray beam axis is perpendicular to the plane of the image receptor to within ±3 degrees; and

6.13.5 Neither tomographic nor stereoscopic radiography is being performed.

6.14 Measuring compliance. Compliance with the requirements of 6.12.1. shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of 6.13 are met. Compliance shall be determined no sooner than 5 second after insertion of the image receptor.

6.15 Operator initiated undersizing. The PBL system shall be capable of operating such that, at the discretion of the operator, the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. Each dimension of the minimum field size at an SID of 100 cm shall be equal to or less than 5 cm. Return to PBL function as described in 6.12.1 shall occur automatically upon any change of image receptor size or SID.

6.16 Override of PBL. A capability may be provided for overriding PBL in case of system failure and for servicing the system. This override may be for all SIDs and image receptor sizes. A key shall be required for any override capability that is accessible to the operator. It shall not be possible to remove the key while PBL is overridden. Each such key switch or key shall be clearly and durably labeled as follows:

6.17 For X-Ray Field Limitation System Failure

6.17.1 The override capability is considered accessible to the operator if it is referenced in the operator’s manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls.

6.18 Field limitation and alignment for spot-film devices. The following requirements shall apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system:

6.18.1 Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.

6.18.2 Neither the length nor width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3 percent of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4 percent of the SID. On spot film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

6.18.3 The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2 percent of the SID.

6.18.4 Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:

6.18.4.1 For spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or

6.18.4.2 For spot-film devices used on fluoroscopic systems that have a variable SID and/or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of 5 cm by 5 cm.

6.19 A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist’s position shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:

6.20 For X-ray Field Limitation System Failure

6.20.1 Source-skin distance.

6.20.1.1 X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the source-skin distance to not less than:

6.20.1.1.1 Eighteen cm if operable above 50 kVp; or

6.20.1.1.2 Ten cm if not operable above 50 kVp.

6.21 Mobile and portable x-ray systems other than dental shall be provided with means to limit the source-skin distance to not less than 30 cm. (See Appendix B for dental systems)

6.22 Beam-on indicators. The x-ray control shall provide visual indication whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

6.23 Reserved.

6.24 Radiation from capacitor energy storage equipment. Radiation emitted from the x-ray tube shall not exceed:

6.24.1 An air kerma of 0.26 microGy (vice 0.03 mR exposure) in 1 minute at 5 cm from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open, the system fully charged, and the exposure switch, timer, or any discharge mechanism not activated. Compliance shall be determined by measurements averaged over an area of 100 square cm, with no linear dimensions greater than 20 cm: and

6.24.2 An air kerma of 0.88 mGy (vice 100 mR exposure) in one hour at 100 cm from the x-ray source, with beam-limiting device fully open, when the system is discharged through the x-ray tube either manually or automatically by use of a discharge switch or deactivation of the input power. Compliance shall be determined by measurements of the maximum air kerma per discharge multiplied by the total number of discharges in 1 hour (duty cycle). The measurements shall be averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

6.25 Primary protective barrier for mammography x-ray systems.

6.25.1 For x-ray systems manufactured after September 5, 1978, and before September 30, 1999, which are designed only for mammography, the transmission of the primary beam through any image receptor support provided with the system shall be limited such that the air kerma 5 cm from any accessible surface beyond the plane of the image receptor supporting device does not exceed 0.88 microGy (vice 0.1 mR exposure) for each activation of the tube.

6.25.2 For mammographic x-ray systems manufactured on or after September 30, 1999:

6.25.2.1 At any SID where exposures can be made, the image receptor support device shall provide a primary protective barrier that intercepts the cross section of the useful beam along every direction except at the chest wall edge.

6.25.2.2 The x-ray system shall not permit exposure unless the appropriate barrier is in place to intercept the useful beam as required in 6.25.2.1.

6.25.2.3 The transmission of the useful beam through the primary protective barrier shall be limited such that the air kerma 5 cm from any accessible surface beyond the plane of the primary protective barrier does not exceed 0.88 microGy (vice 0.1 mR exposure) for each activation of the tube.

6.26 Compliance with the requirements of 6.25.1 and 6.25.2.3 for transmission shall be determined with the x-ray system operated at the minimum SID for which it is designed, at maximum rated peak tube potential, at the maximum rated product of x-ray tube current and exposure time (mAs) for the maximum rated peak tube potential, and by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. The sensitive volume of the radiation measuring instrument shall not be positioned beyond the edge of the primary protective barrier along the chest wall side.

6.27 Beam Limitation, Except Mammographic Systems. The useful beam shall be limited to the area of clinical interest. This shall be deemed to have been met if a positive beam limiting device meeting manufacturer's specifications and the requirements of 6.12 have been properly used or if evidence of collimation is shown on at least three sides or three corners of the film (for example, projections from the shutters of the collimator, cone cutting at the corners, or borders at the film's edge).

6.28 Radiation Exposure Control.

6.28.1 Exposure Initiation. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action. In addition, it shall not be possible to initiate an exposure when the timer is set to a "zero" or "off" position if either position is provided.

6.28.2 Exposure Indication. Means shall be provided for visual indication observable at or from the operator's protected position whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

6.28.3 Operator Protection, Except Veterinary Systems.

6.28.3.1 Stationary Systems. Stationary x-ray systems shall be required to have the x-ray control permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure.

6.28.3.2 Mobile and Portable Systems. Mobile and portable x-ray systems which are:

6.28.3.2.1 Used continuously for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of 6.28.3.1

6.28.3.2.2 Used for less than one week at the same location shall be provided with either a protective barrier at least 2 meters (6.5 feet) high for operator protection during exposures, or means shall be provided to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during the exposure.

6.29 Operator Protection for Veterinary Systems. All stationary, mobile or portable x-ray systems used for veterinary work shall be provided with either a 2 meter (6.5 feet) high protective barrier for operator protection during exposures, or shall be provided with means to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during exposures. Refer to Appendix B for hand-held intraoral dental radiographic units used in veterinary practice.

6.30 Tube Stands for Portable X-Ray Systems. A tube stand or other mechanical support shall be used for portable x-ray systems, so that the x-ray tube housing assembly need not be hand-held during exposures.

In addition to the applicable provisions of 3.0, 4.0, 6.0, the requirements of 7.0 apply to x-ray equipment and associated facilities used for dental intraoral radiography. Requirements for extraoral dental radiographic systems are covered in 6.0.

7.1 Radiation Exposure Control. Means shall be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure shall not be initiated without such an action.

7.1.1 Exposure Control Location and Operator Protection.

7.2 Stationary x‑ray systems shall be required to have the x‑ray exposure control permanently mounted in a protected area, so that the operator is required to remain in that protected area during the entire exposure; and

7.3 Mobile and portable x‑ray systems which are:

7.3.1 Used for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of 7.1;

7.3.2 Used for less than one week in the same location shall be provided with either a protective barrier at least 2 meters (6.5 feet) high for operator protection, or means to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly while making exposures.

7.4 kVp Limitations. Dental x-ray machines with a nominal fixed kVp of less than 50 kVp shall not be used to make diagnostic dental radiographs of humans.

7.5 Administrative Controls.

7.5.1 Patient and film holding devices shall be used when the techniques permit.

7.5.2 The tube housing and the PID for a permanently mounted intraoral dental system shall not be hand-held during an exposure. Appendix B specifies requirements for the use of intraoral dental radiographic units designed to be hand-held during patient examination.

7.5.3 Dental fluoroscopy without image intensification shall not be used.

8.1 Definitions. In addition to the definitions provided in A.2 and 2.0 of these regulations, the following definitions shall be applicable to 8.0

"Computed tomography dose index" (CTDI) means the integral of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is:

z = Position along a line perpendicular to the tomographic plane;

D(z) = Dose at position z;

T = Nominal tomographic section thickness;

n = Number of tomograms produced in a single scan.

This definition assumes that the dose profile is centered around z=0 and that, for a multiple tomogram system, the scan increment between adjacent scans is nT.

"Contrast scale" means the change in the linear attenuation coefficient per CTN relative to water, that is:

where:

"CT conditions of operation" means all selectable parameters governing the operation of a CT x-ray system including nominal tomographic section thickness, filtration, and the technique factors as defined in 2.0.

"CT dosimetry phantom" means the phantom used for determination of the dose delivered by a CT x-ray system. The phantom shall be a right circular cylinder of polymethl-methacrylate of density 1.19±0.01 grams per cubic centimeter. The phantom shall be at least 14 centimeters in length and shall have diameters of 32.0 centimeters for testing any CT system designed to image any section of the body (whole body scanners) and 16.0 centimeters for any system designed to image the head (head scanners) or for any whole body scanner operated in the head scanning mode. The phantom shall provide means for the placement of a dosimeter(s) along its axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom. Means for the placement of a dosimeter(s) or alignment device at other locations may be provided for convenience. Any effect on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom.

"CT Number" means the number used to represent the x-ray attenuation associated with each elemental area of the CT image:

where:

k = A constant, a normal value of 1,000 when the Houndsfield scale of CTN is used;

"Dose profile" means the dose as a function of position along a line.

"Modulation transfer function" means the modulus of the Fourier transform of the impulse response of the system.

"Multiple tomogram system" means a computed tomography x-ray system which obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram.

"Noise" means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:

where:

"Nominal tomographic section thickness" means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.

"Picture element" means an elemental area of a tomogram.

"Reference plane" means a plane which is displaced from and parallel to the tomographic plane.

"Remanufacturing" means modifying a CT system in such a way that the resulting dose and imaging performance become substantially equivalent to any CT x-ray system manufactured by the original manufacturer on or after November 29, 1984. Any reference in this subsection to “manufacture,” “manufacturer,” or “manufacturing” includes remanufacture, remanufacturing, respectively.

"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

"Scan increment" means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.

"Scan sequence" means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.

"Sensitivity profile" means the relative response of the CT x-ray system as a function of position along a line perpendicular to the tomographic plane.

"Single tomogram system" means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.

"Tomographic plane" means that geometric plane which the manufacturer identified as corresponding to the output tomogram.

"Tomographic section" means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

8.2 Requirements for Equipment.

8.2.1 Termination of Exposure.

8.2.1.1 Means shall be provided to terminate the x-ray exposure automatically by either de-energizing the x-ray source or shuttering the x-ray beam in the event of equipment failure affecting data collection. Such termination shall occur within an interval that limits the total scan time to no more than 110 percent of its preset value through the use of either a backup timer or devices which monitor equipment function.

8.2.1.2 A visible signal shall indicate when the x-ray exposure has been terminated through the means required by Subdivision 8.2.1.1.

8.2.1.3 The operator shall be able to terminate the x-ray exposure at any time during a scan, or series of scans under CT x-ray system control, of greater than one-half second duration.

8.3 Tomographic Plane Indication and Alignment.

8.3.1 For any single tomogram system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.

8.3.2 For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. This reference plane can be offset from the location of the tomographic planes.

8.3.3 If a device using a light source is used to satisfy the requirements of Subdivisions 8.3.1 or 8.3.2, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.

8.4 Beam-On and Shutter Status Indicators and Control Switches.

8.4.1 The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced and, if applicable, whether the shutter is open or closed.

8.4.2 Each emergency button or switch shall be clearly labeled as to its function.

8.5 Indication of CT Conditions of Operation. The CT x-ray system shall be designed such that the CT conditions of operation to be used during a scan or a scan sequence shall be indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.

8.6 Extraneous Radiation. When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by 4.3.

8.7 Maximum Surface CTDI Identification. The angular position where the maximum surface CTDI occurs shall be identified to allow for reproducible positioning of a CT dosimetry phantom.

8.8 Additional Requirements Applicable to CT X-Ray Systems Containing a Gantry Manufactured After September 3, 1985.

8.8.1 The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 millimeters.

8.8.2 If the x-ray production period is less than one-half second, the indication of x-ray production shall be actuated for at least one-half second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.

8.8.3 The deviation of indicated scan increment versus actual increment shall not exceed plus or minus 1 millimeter with any mass from 0 to 100 kilograms resting on the support device. The patient support device shall be incremented from a typical starting position to the maximum incremented distance or 30 centimeters, whichever is less, and then returned to the starting position. Measurement of actual versus indicated scan increment may be taken anywhere along this travel.

8.8.4 Premature termination of the x-ray exposure by the operator shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.

8.9 Facility Design Requirements.

8.9.1 Aural Communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel.

8.9.2 Viewing Systems.

8.9.2.1 Windows, mirrors, closed-circuit television, or an equivalent shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

8.9.2.2 When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) shall be available for use in the event of failure of the primary viewing system.

8.10 Surveys, Calibrations, Spot Checks, and Operating Procedures.

8.11 Surveys.

8.11.1 All CT x-ray systems installed after [insert the effective date of the regulations] and those systems not previously surveyed shall have a survey made by, or under the direction of, a qualified medical physicist. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.

8.11.2 The registrant [licensee] shall obtain a written report of the survey from the qualified medical physicist, and a copy of the report shall be made available to the Agency upon request.

8.12 Radiation Calibrations.

8.12.1 The calibration of the radiation output of the CT x-ray system shall be performed by, or under the direction of, a qualified medical physicist who is physically present at the facility during such calibration.

8.12.2 The calibration of a CT x-ray system shall be performed after initial installation and before use on human patients, annually or at intervals specified by a qualified medical physicist, and after any change or replacement of components which, in the opinion of the qualified medical physicist, could cause a change in the radiation output.

8.12.3 The calibration of the radiation output of a CT x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding 2 years.

8.12.4 CT dosimetry phantom(s) shall be used in determining the radiation output of a CT x-ray system. Such phantom(s) shall meet the following specifications and conditions of use:

8.12.4.1 CT dosimetry phantom(s) shall be right circular cylinders of polymethyl methacrylate of density 1.19 plus or minus 0.01 grams per cubic centimeter. The phantom(s) shall be at least 14 centimeters in length and shall have diameters of 32.0 centimeters for testing CT x-ray systems designed to image any section of the body and 16.0 centimeters for systems designed to image the head or for whole body scanners operated in the head scanning mode;

8.12.4.2 CT dosimetry phantom(s) shall provide means for the placement of a dosimeter(s) along the axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;

8.12.4.3 Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom;

8.12.4.4 All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.

8.12.5 The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.

8.12.6 Calibration shall meet the following requirements:

8.12.6.1 The dose profile along the center axis of the CT dosimetry phantom for the minimum, maximum, and midrange values of the nominal tomographic section thickness used by the registrant shall be measurable. Where less than 3 nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness;

8.12.6.2 The CTDI2/ along the two axes specified in Subdivision 8.12.4.2 shall be measured. The CT dosimetry phantom shall be oriented so that the measurement point 1.0 centimeter from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant;

8.12.6.3 The spot checks specified in 8.13 shall be made.

8.12.7 Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the Agency.

8.13 Spot Checks.

8.13.1 The spot-check procedures shall be in writing and shall have been developed by a qualified medical physicist.

8.13.2 The spot-check procedures shall incorporate the use of a CT dosimetry phantom which has a capability of providing an indication of contrast scale, noise, nominal tomographic section thickness, the resolution capability of the system for low and high contrast objects, and measuring the mean CTN for water or other reference material.

8.13.3 All spot checks shall be included in the calibration required by 8.11.2. and at time intervals and under system conditions specified by a qualified medical physicist.

8.13.4 Spot checks shall include acquisition of images obtained with the CT dosimetry phantom(s) using the same processing mode and CT conditions of operation as are used to perform calibrations required by 8.11.2. The images shall be retained, until a new calibration is performed, in two forms as follows:

8.13.4.1 Photographic copies of the images obtained from the image display device; and

8.13.4.2 Images stored in digital form on a storage medium compatible with the CT x-ray system.

8.13.5 Written records of the spot checks performed shall be maintained for inspection by the Agency.

8.14 Operating Procedures.

8.14.1 The CT x-ray system shall not be operated except by an individual who has been specifically trained in its operation.

8.14.2 Information shall be available at the control panel regarding the operation and calibration of the system. Such information shall include the following:

8.14.2.1 Dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;

8.14.2.2 Instructions on the use of the CT dosimetry phantom(s) including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent spot checks conducted on the system;

8.14.2.3 The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and

8.14.2.4 A current technique chart available at the control panel which specifies for each routine examination the CT conditions of operation and the number of scans per examination.

8.14.3 If the calibration or spot check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the qualified medical physicist, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified medical physicist.

9.1 Requirements for Certification.

9.1.1 Only x-ray systems, pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Public Law 105-248, and 21 C.F.R. Part 900, shall be used for screening and diagnostic mammography.

9.1.2 A facility performing mammography shall have a valid certificate issued by the U.S. Department of Health and Human Services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Public Law 105-248, and 21 C.F.R. Part 900.

9.1.3 A facility performing mammography shall ensure that the additional mammography activities of processing the x-ray film, interpreting the image, and maintaining viewing conditions, wherever performed, meet all quality standards pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Public Law 105-248, and 21 C.F.R. Part 900.

[Current] federal regulations, 21 CFR Part 900, [dated] referring to states with certifying authority, is incorporated in its entirety in Part F.

11.1 Bone densitometry systems shall be:

11.1.1 Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C – Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;

11.1.2 Registered [licensed] in accordance with Part B of these regulations; and

11.1.3 Maintained and operated in accordance with the manufacturer’s specifications.

11.2 Equipment Requirements. Systems with stepless collimators shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond 2 percent of the SID.

11.3 Operators of bone densitometry systems shall be:

11.3.1 Licensed, certified, or permitted as a radiologic technologist or technician [by the Agency]; or

11.3.2 Licensed as a practitioner of the healing arts; or

11.3.3 Permitted, certified, or approved [by the Agency] as a bone densitometry operator

11.4 During the operation of any bone densitometry system:

11.4.1 The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination.

11.5 The registrant [licensee] shall keep maintenance records for bone densitometry systems as prescribed by 11.1.3. These records shall be maintained for inspection by the Agency.

11.6 Bone densitometry on human patients shall be conducted only:

11.6.1 Under a prescription of a licensed practitioner of the healing arts; or

11.6.2 Under a screening program approved by the Agency.

11.7 Any person proposing to conduct a bone densitometry screening program shall submit the information outlined in Appendix A of this Part with the exception of g., h., i., j., k., and m., and include the name and address of the individual who will interpret the screening results.

12.1 All registrants [licensees] of diagnostic x-ray imaging equipment shall establish and maintain a quality assurance program consisting of quality control assessments addressing at least the following items:

12.1.1 Administration.

12.1.1.1 Written standard operating procedures on radiation protection and the practice of radiologic technology reviewed and updated annually by management;

12.1.1.2 Employee review and written acknowledgment of standard operating procedures and policies on radiation protection and the practice of radiologic technology;

12.1.1.3 Credentialing of practitioners, medical physicists, and x-ray equipment operators; and

12.1.1.4 Record retention in accordance with state statutes, regulations, but in no case less than three years.

12.1.2 Film Processing equipment.

12.1.2.1 Compliance with Section 3.0;

12.1.2.2 Film processor performance to include medium density, density difference, and base + fog;

12.1.2.3 Darkroom fog;

12.1.3 Radiographic equipment.

12.1.3.1 Compliance with performance standards in Sections 4.0 and 6.0;

12.1.3.2 Entrance skin exposure rates of selected patient examinations;

12.1.3.3 Image printing and viewing equipment;

12.1.3.4 Measurement of low and high contrast resolution; and

12.1.3.5 Radiation protection.

12.1.4 Fluoroscopic equipment.

12.1.4.1 Compliance with performance standards in Sections 4.0 and 5.0;

12.1.4.2 Entrance skin exposure rates of selected patient examinations;

12.1.4.3 Image printing and viewing equipment;

12.1.4.4 Measurement of low and high contrast resolution; and

12.1.4.5 Radiation protection.

12.1.5 Computerized tomography equipment.

12.1.5.1 Compliance with performance standards in Section 8.0;

12.1.5.2 CT number;

12.1.5.3 Low contrast and high contrast resolution;

12.1.5.4 Dosimetry of selected patient examinations to include pediatric patients if applicable;

12.1.5.5 Image printing and viewing equipment; and

12.1.5.6 Radiation protection.

12.1.6 Bone densitometry equipment.

12.1.6.1 Compliance with requirements in Section 11.0

12.1.7 Structural shielding for new facilities with x-ray equipment.

12.1.7.1 Pre-construction shielding design and evaluation; and

12.2 Post-construction radiation protection survey.

12.2.1 Structural shielding for modifying use or equipment in existing facility.

12.2.1.1 Re-evaluation of shielding design; and

12.2.1.2 Post-modification radiation protection survey.

12.3 The registrant [licensee] shall assign qualified personnel to fully implement the quality assurance program.

12.4 Quality control assessments for Section 12.1.1 may be assigned to qualified personnel who possess the requisite training and/or experience.

12.5 Quality control assessments for Section 12.1.1 shall be conducted by, or under the direction of, a qualified medical physicist.

12.6 The registrant [licensee] and/or qualified medical physicist shall determine the frequency of quality control tests.

12.7 The quality assurance program shall be in written form and available for review by the Agency.

12.8 Equipment used for compliance with the provisions of this section shall be properly calibrated and maintained in accordance with accepted professional standards.

This Section does not pertain to quality assurance for mammography equipment.

INFORMATION TO BE SUBMITTED BY PERSONS PROPOSING TO CONDUCT HEALING ARTS SCREENING

Persons requesting that the Agency approve a healing arts screening program shall submit the following information and evaluation:

1. Name and address of the applicant and, where applicable, the names and addresses of agents within this State;

2. Diseases or conditions for which the x‑ray examinations are to be used in diagnoses;

3. A description of the x‑ray examinations proposed in the screening program i.e., type and number of views;

4. Description of the population to be examined in the screening program, i.e., age range, sex, physical condition, and other appropriate information;

5. An evaluation of any known alternate methods not involving ionizing radiation that could achieve the goals of the screening program and why these methods are not used instead of the x‑ray examinations;

6. An evaluation by a qualified medical physicist of the x‑ray system(s) to be used in the screening program. The evaluation shall include the following:

a. Documentation that such system(s) satisfy all requirements of these regulations;

b. measurement of patient exposures from the x-ray examinations to be performed;

7. A description of the diagnostic x-ray quality control program;]

8. A copy of the technique chart for the x‑ray examination procedures to be used;

9. The qualifications of each individual who will be operating the x‑ray system(s);

10. The qualifications of the individual who will be supervising the operators of the x‑ray system(s). The extent of supervision and the method of work performance evaluation shall be specified;

11. The name and address of the practitioner licensed in the state who will interpret the radiograph(s);

12. Procedures to be used in advising the individuals screened and their practitioner of the healing arts or health care provider of the results of the screening procedure and any further medical needs indicated;

13. Procedures for the retention or disposition of the radiographs and other records pertaining to the x‑ray examinations;

14. Frequency of screening of individuals; and

15. The duration of the screening program.

HAND-HELD INTRAORAL DENTAL RADIOGRAPHIC UNIT REQUIREMENTS FOR USE

This appendix list the required information/documentation one must provide when requesting a variance for the use of a hand held unit. Such variance shall be specific to the particular facility location only.

The use of hand-held intraoral dental radiographic units must be approved as a variance by the Authority on Radiation Protection Board. Applications for variance must specify the conditions of use and precautions that will be put in place to assure safety and health protection equivalent to that of a stationary device.

The Agency may specify any of, but not be limited to, the following requirements for intraoral dental radiographic units designed to be operated as a hand-held unit:

1. For all uses:

a. The use of hand held intraoral dental radiographic units must be approved by the agency prior to use.

b. Operators of hand-held intraoral dental radiographic units shall be specifically trained to operate such equipment.

c. When operating a hand-held intraoral dental radiographic unit, operators shall wear a lead apron and thyroid collar, unless otherwise authorized by the Agency or a qualified health or medical physicist.

d. A hand-held intraoral dental radiographic unit shall be held without any motion during a patient examination. A tube stand may be utilized to immobilize a hand-held intraoral dental radiographic unit during patient examination.

e. Unless otherwise authorized by the Agency, a hand-held intraoral dental radiographic unit shall be used with a secondary radiation block.

f. The operator shall ensure there are no bystanders within a radius of at least six feet from the patient being examined with a hand-held intraoral radiographic unit.

2. Additional requirements for operatories in permanent facilities:

a. Hand-held intraoral dental radiographic units shall be used for patient examinations in dental operatories that meet the structural shielding requirements specified by the Agency or by a qualified health or medical physicist.

b. Hand-held intraoral dental radiographic units shall not be used for patient examinations in hallways and waiting rooms.

3. The following sections prohibit the use of hand held devices:

a. 3.1.9.3. Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient(s) to a stationary x-ray installation. The use of hand held devices must be approved by the Agency utilizing the criteria in Appendix B.

b. 6.28.3.2. Mobile and Portable Systems. Mobile and portable x-ray systems which are:

6.28.3.2.1 Used continuously for greater than one week in the same location, i.e., a room or suite, shall meet the requirements of 6.28.3.1;

6.28.3.2.2 Used for less than one week at the same location shall be provided with either a protective barrier at least 2 meters (6.5 feet) high for operator protection during exposures, or means shall be provided to allow the operator to be at least 2.7 meters (9 feet) from the tube housing assembly during the exposure.

c. 6.30 Tube Stands for Portable X-Ray Systems. A tube stand or other mechanical support shall be used for portable x-ray systems, so that the x-ray tube housing assembly need not be hand-held during exposures.

d. 7.5.2 The tube housing and the PID for a permanently mounted intraoral dental system shall not be hand-held during an exposure. Appendix B specifies requirements for the use of intraoral dental radiographic units designed to be hand-held during patient examination.

MEDICAL DIAGNOSTIC AND INTERVENTIONAL X-RAY AND IMAGING SYSTEMS

This Part establishes requirements, for which a registrant is responsible, for use of diagnostic and interventional x-ray equipment and imaging systems by, or under the supervision of, an individual authorized by and licensed in accordance with State statutes to engage in the healing arts (dental, medical, or veterinary medicine). The provisions of this Part are in addition to, and not in substitution for, other applicable provisions of Parts A, B, D, G J, I, and X, of these regulations.

As used in this Part, the following definitions apply:

"Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer.

“Agency” means the Division of Public Health, Delaware Department of Health and Social Services.

"Air kerma" means kerma in air (see definition of Kerma).

"Air kerma rate (AKR)" means the air kerma per unit time.

"Alert value" means a dose index (e.g., of CTDIvol (mGy) or DLP (mGy-cm)) that is set by the registrant to trigger an alert to the CT operator prior to scanning within an ongoing examination. The Alert value represents a universal dose index value well above the registrant established range for the examination that warrants more stringent review and consideration before proceeding.

"Aluminum equivalent" means the thickness of type 1100 aluminum alloy / affording the same attenuation, under specified conditions, as the material in question.

“Annual” means approximately every 12 months and not to exceed 14 months.

"Articulated joint" means a joint between two separate sections of a tabletop which joint provides the capacity of one of the sections to pivot on the line segment along which the sections join.

"Attenuation block" means a block or stack of type 1100 aluminum alloy, or aluminum alloy having equivalent attenuation, with dimensions 20 centimeters (cm) or larger by 20 cm or larger by 3.8 cm, that is large enough to intercept the entire x-ray beam.

"Automatic exposure control (AEC)" means a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation.

"Automatic exposure rate control (AERC)" means a device which automatically controls one or more technique factors in order to obtain, at a preselected location(s), a required quantity of radiation per unit time.

"Barrier" (See "Protective barrier").

"Beam axis" means a line from the source through the centers of the x-ray fields.

"Beam-limiting device" means a device which provides a means to restrict the dimensions of the x- ray field.

"Bone densitometer" means a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

"Bone densitometry" means a noninvasive measurement of certain physical characteristics of bone that reflect bone strength. Test results are typically reported as bone mineral content or density and are used for diagnosing osteoporosis, estimating fracture risk, and monitoring changes in bone mineral content.

"C-arm fluoroscope" means a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.

"Cantilevered tabletop" means a tabletop designed such that the unsupported portion can be extended at least 100 cm beyond the support.

"Cassette holder" means a device, other than a spot-film device, that supports and/or fixes the position of the image receptor during a radiographic exposure.

where:

n = Number of observations sampled.

"Computed radiography (CR; also see DR)" means a digital x-ray imaging method in which a photo-stimulable phosphor is used to capture and store a latent image. The latent image is read out by stimulating the phosphor with a laser. Computed radiography systems may use cassettes to house the phosphor, or it may be integrated into a digital radiography system.

"Computed tomography (CT)" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.

Where: D(z) = the radiation dose profile along the z-axis,

N = the number of tomographic sections imaged in a single axial scan. This is equal to the number of data channels used in a particular scan. The value of N may be less than or equal to the maximum number of data channels available on the system, and

T = the width of the tomographic section along the z-axis imaged by one data channel. In multiple-detector-row (multislice) CT scanners, several detector elements may be grouped together to form one data channel. In single-detector-row (single-slice) CT, the z-axis collimation (T) is the nominal scan width.

"Cone Beam Computed Tomography (CBCT)" is a volumetric imaging modality. Volumetric data are acquired using two dimensional digital detector arrays, and a cone-shaped x-ray beam (instead of fan-shaped) that rotates around the patient. Reconstruction algorithms can be used to generate images of any desired plane.

“Cone Beam CT” (CBCT) means a method of computed tomography that creates a three-dimensional cone-shaped beam that circles the patient once to generate an image.

"Control panel" means that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, keypads, touchscreens, and other hardware necessary for manually setting the technique factors.

"Cradle" means:

(1) A removable device which supports and may restrain a patient above an x-ray table; or

(2) A device;

(i) Whose patient support structure is interposed between the patient and the image receptor during normal use;

(ii) Which is equipped with means for patient restraint; and

(iii) Which is capable of rotation about its long (longitudinal) axis.

"CT" (See "Computed tomography").

"CT conditions of operation" means all selectable parameters governing the operation of a CT x-ray system including nominal tomographic section thickness, filtration, and the technique factors as defined in Part F, Section 2.0.

"CTDI100" means the accumulated multiple scan dose at the center of a 100-mm scan and underestimates the accumulated dose for longer scan lengths. It is thus smaller than the equilibrium dose. The CTDI100 requires integration of the radiation dose profile from a single axial scan over specific integration limits. In the case of CTDI100, the integration limits are +50 mm, which corresponds to the 100-mm length of the commercially available “pencil” ionization chamber. CTDI100 is acquired using a 100-mm long, 3-cc active volume CT “pencil” ionization chamber and one of the two standard CTDI acrylic phantoms (16 and 32 cm diameter) and a stationary patient table. The equation is:

"CTDIvol" see "Volume Computed Tomography Dose Index (CTDIvol)"

"CTDIw" see "Weighted Computed Tomography Dose Index (CTDIw)"

"CT gantry" means tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold and/or enclose these components within a computed tomography system.

where:

k = A constant, a normal value of 1,000 when the Houndsfield scale of CT number is used;

"Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.

"Detector" (See "Radiation detector")

"Diagnostic reference level" (DRL) is an investigational level used to identify unusually high radiation doses or dose rates for common medical X-ray imaging procedures. DRLs are suggested action levels above which a facility should review its methods and determine if acceptable image quality can be achieved at lower doses. DRLs should not be applied to an individual patient.

"Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.

"Diagnostic x-ray system" means an x-ray system designed for irradiation of any part of the human [or animal] body for the purpose of diagnosis or visualization.

"Digital radiography (DR)" means an x-ray imaging method (or radiography) which produces a digital rather than analog image. DR includes both computed radiography and direct digital radiography.

"Direct digital radiography (DDR; also see CR and DR)" means an x-ray imaging method in which a digital sensor, usually incorporating a thin-film transistor, is used to capture an x-ray image. Some DDR systems use a scintillator to convert x-rays to light and a photodiode array to convert light to charge, while others use a photoconductor to convert x-rays directly to charge, which is stored on the thin-film transistor.

"Direct scattered radiation" means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").

"Direct supervision" means a qualified, licensed practitioner must exercise general supervision, and be immediately available either physically or by an electronic device, to furnish assistance and direction throughout the performance of the procedures. It does not mean that the licensed practitioner must be present in the room when the procedure is being performed.

"Dose" means the absorbed dose as defined by the International Commission on Radiation Units and Measurements. The absorbed dose, D, is the quotient of de by dm, where de is the mean energy imparted to matter of mass dm; thus D=de/dm, in units of J/kg, where the special name of the unit of absorbed dose is gray (Gy).

"Dose area product (DAP) (aka kerma-area product (KAP))" means the product of the air kerma and the area of the irradiated field and is typically expressed in Gy-cm2, so it does not change with distance from the x-ray tube.

"Dose length product (DLP)" means the indicator of the integrated radiation dose from a complete CT examination. It addresses the total scan length by the formula:

DLP (mGy-cm) = CTDIvol (mGy) x scan length (cm)

"Dose profile" means the dose as a function of position along a line.

"Effective dose (E)" means the sum of the tissue-weighted equivalent doses for the radiosensitive tissues and organs of the body. It is given by the expression E = ?T (wT HT), in which HT is the equivalent dose in tissue or organ T and wT is the tissue weighting factor for tissue or organ T. The unit of E and HT is joule per kilogram (J·kg-1), with the special name sievert (Sv).

"Equipment" (See "X-ray equipment") means x-ray equipment.

"Exposure (X)" means the quotient of dQ by dm where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated or created by photons in air of mass dm are completely stopped in air; thus X=dQ/dm, in units of C/kg. A second meaning of exposure is the process or condition during which the x-ray tube produces x-ray radiation.

"Field emission equipment" means equipment which uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

"Filter" means material placed in the useful beam to preferentially absorb selected radiations.

"Fluoroscopically-Guided Interventional (FGI) Procedures" means an interventional diagnostic or therapeutic procedure performed via percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to localize or characterize a lesion, diagnostic site, or treatment site, to monitor the procedure, and to control and document therapy.

"Fluoroscopic imaging assembly" means a subsystem in which x-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

"Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation.

"Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term "radioscopy" in the standards of the International Electrotechnical Commission.

"Focal spot (actual)" means the area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.

"General purpose radiographic x-ray system" means any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.

"General supervision" means the procedure is performed under the overall direction and control of the qualified practitioner but the qualified practitioner is not required to be physically present during the performance of the procedure.

"Half-value layer (HVL)" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.

"Hand-held x-ray equipment" means x-ray equipment that is designed to be hand-held during operation.

"Healing arts screening" means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.

"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, i.e., kVp x mA x second.

"HVL" (See "Half-value layer").

"Image intensifier" means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.

"Image receptor" means any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term “image receptor” shall mean the preselected portion of the device.

"Irradiation" means the exposure of matter to ionizing radiation.

"Isocenter" means the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center.

"Kerma" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma, K, is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all the charged particles liberated by uncharged particles in a mass dm of material; thus K=dEtr/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as "air kerma."

"Kerma-area product (KAP)" (See "dose area product")

"Kilovolts peak" (See "Peak tube potential").

"kV" means kilovolts.

"kVp" (See "Peak tube potential").

"kWs" means kilowatt second.

"Last-image hold (LIH) radiograph" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

"Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

"Leakage radiation" means radiation emanating from the diagnostic source assembly except for:

(1) The useful beam; and

(2) Radiation produced when the exposure switch or timer is not activated.

"Leakage technique factors" means the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows:

(1) For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs (or 10 mAs) or the minimum obtainable from the unit, whichever is larger;

(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; and

(3) For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.

“Licensed practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, advanced practice nursing, or veterinary medicine in this state.

"Light field" means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.

"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percent of the load line potential; that is,

Percent line-voltage regulation = 100 (Vn-Vl)/Vl

where:

Vn = No-load line potential; and

Vl = Load line potential.

"mA" means milliampere.

"mAs" means milliampere second.

"Medical event" means one or more of the following criteria have occurred:

a. Event which results in an unintended dose greater than:

i. 0.5 Gy (50 rad) to any organ or tissue, or

ii. 0.05 Sv (5 rem) total effective dose equivalent for the procedure, or

b. Event involves wrong patient or wrong site for entire diagnostic exam (procedure/service) and

i. exceeds 0.5 Gy (50 rad) to an organ or tissue, or

ii. exceeds 0.05 Sv (5 rem) total effective dose equivalent for the procedure, or

c. Involves any equipment failure, personnel error, accident, mishap or other unusual occurrence with the administration of ionizing radiation that exceeds:

i. 0.5 Gy (50 rad) to an organ or tissue, or

ii. 0.05 Sv (5 rem) total effective dose equivalent for the procedure.

"Mobile x-ray equipment" (See "X-ray equipment").

"Mode of operation" means, for fluoroscopic systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.

"Multiple tomogram system" means a computed tomography x-ray system which obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram.

where:

"Nominal tomographic section thickness" means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.

"Notification value" means a protocol-specific dose index (e.g. CTDIvol(mGy) or of DLP(mGy-cm)) that is set by the registrant to trigger a notification to the CT operator prior to scanning when the dose index exceeds the established range for the examination.

"Patient" means an individual or animal subjected to healing arts examination, diagnosis or treatment.

"PBL" See "Positive beam limitation"

"Peak tube potential" means the maximum value of the potential difference across the x-ray tube during an exposure.

"Personal supervision" means a qualified practitioner must exercise General Supervision and be present in the room or adjacent control area during the performance of the procedure.

"Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.

"Photostimulable storage phosphor (PSP)" means a material used to capture and store radiographic images in computed radiography systems.

"Picture element" means an elemental area of a tomogram.

"PID" (See "Position indicating device").

"Pitch" means the table incrementation, in CT, per x-ray tube rotation, divided by the nominal x-ray beam width at isocenter.

"Portable x-ray equipment" (See "X-ray equipment").

"Position indicating device (PID)" means a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

"Positive beam limitation" means the automatic or semi-automatic adjustment of an x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.

"Primary protective barrier" means the material, excluding filters, placed in the useful beam to reduce the radiation exposure [beyond the patient and cassette holder] for protection purposes.

"Protective apron" means an apron made of radiation absorbing materials used to reduce radiation exposure.

"Protocol" means a collection of settings and parameters that fully describe an examination.

"Pulsed mode" means operation of the x-ray system such that the x-ray tube current is pulsed by the x-ray control to produce one or more exposure intervals of duration less than one-half second.

“Qualified expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which State Radiation Service Provider registration is sought in accordance with Regulation 4465, Part B. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example formal education or individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with Regulation 4465, Part F and Regulation 4465, Part X of these regulations, as amended.

"Qualified medical physicist (QMP)" means an individual who meets each of the following credentials:

1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and

2. Has been granted certification in the specific subfield(s) of medical physics with its associated medical health physics aspects by an appropriate national certifying body and abides by the certifying body's requirements for continuing education; and/or

3. Is credentialed in accordance with Part X, subsection 3.4, as amended.

"Quality Assurance" means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected, and reported to the appropriate regulatory authorities as required.

"Radiation detector" means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation.

"Radiation Protocol Committee (RPC)" means the representative group of qualified individuals in a CT or FGI facility responsible for the ongoing review and management of CT or FGI protocols to ensure that exams being performed achieve the desired diagnostic image quality at the lowest radiation dose possible while properly exploiting the capabilities of the equipment being used.

"Radiation therapy simulation system" means a radiographic or fluoroscopic x ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

"Radiograph" means an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.

"Radiography" means a technique for generating and recording an x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.

"Recording" means producing a retrievable form of an image resulting from x-ray photons.

"Reference plane" means a plane which parallel to and which can be offset (as specified in manufacturer information provided to users) from the location of the tomographic plane(s).

"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data may be collected simultaneously during a single scan for the production of one or more tomograms.

"Scan increment" means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.

"Scan sequence" means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.

"Scan time" means the time elapsed during the accumulation of x-ray transmission data for a single scan.

"Scattered radiation" means radiation that, during passage through matter, has been deviated in direction (See "Direct scattered radiation").

"Sensitivity profile" means the relative response of the CT x-ray system as a function of position along a line perpendicular to the tomographic plane.

"Shutter" means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

"SID" (See "Source-image receptor distance").

"Single tomogram system" means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.

"Size-specific dose estimate (SSDE)" means a patient dose estimate which takes into consideration corrections based on the size of the patient, using linear dimensions measured on the patient or patient images.

"Source" means the focal spot of the x-ray tube.

"Source-image receptor distance" means the distance from the source to the center of the input surface of the image receptor.

"Source-skin distance (SSD)" means the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient skin surface.

"Spot-film" / means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.

"Spot-film device" means a device intended to transport and/or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of the fluoroscopic image receptor for the purpose of producing a radiograph.

"Stationary x-ray equipment" (See "X-ray equipment").

"Stray radiation" means the sum of leakage and scattered radiation.

"Substantial radiation dose level" (SRDL) means an appropriately-selected dose used to trigger additional dose-management actions during a procedure and medical follow-up for a radiation level that might produce a clinically-relevant injury in an average patient.

"Technique factors" means the following conditions of operation:

(1) For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);

(2) For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of x-ray pulses;

(3) For CT equipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;

(4) For CT equipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and

(5) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs.

"Tomogram" means the depiction of the x-ray attenuation properties of a section through the body.

"Tomographic plane" means that geometric plane which the manufacturer identified as corresponding to the output tomogram.

"Tomographic section" means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

"Tube" means an x-ray tube, unless otherwise specified.

"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

"Unintended" radiation dose in diagnostic or interventional x-ray means a patient radiation dose determined to have resulted from a human error or equipment malfunction during the procedure.

"Useful beam" means the radiation which passes through the tube housing port and the aperture of the beam limiting device when the exposure switch or timer is activated.

"Visible area" means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

"Volume Computed Tomography Dose Index (CTDIvol)" means a radiation dose parameter derived from the CTDIw (weighted or average CTDI given across the field of view). The formula is:

CTDIvol = (N)(T)(CTDIw)/I, where

N = number of simultaneous axial scans per x-ray source rotation,

T = thickness of one axial scan (mm), and

I = table increment per axial scan (mm).

Thus,

CTDIvol = CTDIw / pitch

Where 1/3 and 2/3 approximate the relative areas represented by the center and edge values derived using the 16 or 32 cm acrylic phantom. CTDIw uses CTDI100 and an f-factor for air (0.87 rad/R or 1.0 mGy/mGy).

"X-ray control" means a device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an x-ray exposure.

"X-ray equipment" means an x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows:

(1) "Mobile x-ray equipment" means x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled;

(2) "Portable x-ray equipment" means x-ray equipment designed to be hand-carried; and

(3) "Stationary x-ray equipment" means x-ray equipment which is installed in a fixed location.

(4) "Hand-held x-ray equipment" means x-ray equipment that is designed to be hand-held during operation.

"X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The x-ray exposure control may include such associated equipment as timers and back-up timers.

"X-ray field" means that area of the intersection of the useful beam and any one of a set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR is one-fourth of the maximum in the intersection.

"X-ray high-voltage generator" means a device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for trans-forming alternating current to direct current, filament transformers for the x-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.

"X-ray system" means an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.

"X-ray table" means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography and/or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film device beneath the tabletop.

"X-ray tube" means any electron tube which is designed for the conversion of electrical energy into x-ray energy.

3.1 Radiation Safety Requirements. The registrant shall be responsible for directing the operation of the x-ray system(s) under his or her administrative control and shall assure that the requirements of these regulations are met in the operation of the x-ray system(s).

3.1.1 The registrant shall have a radiation safety program. The radiation safety program shall include but not be limited to the following:

3.1.1.1 The use of ionizing radiation within its purview is performed in accordance with existing laws and regulations.

3.1.1.2 All persons are protected as required by Regulation 4465, Part D, Standards for Protection Against Radiation, of these regulations.

3.1.1.3 Upon discovery of a medical event, the registrant shall:

3.1.1.3.1 Contact the Agency regarding the medical event within one business day;

3.1.1.3.2 Provide a written report, including the analysis of the medical event, by a QMP (QE) to the Agency within 15 business days;

3.1.1.3.3 Provide a clinical summary to the prescribing physician and patient within 15 business days; and

3.1.1.4 Maintain record of the medical event as part of the patient's permanent medical record, and

3.1.1.5 Maintain record of the medical event as reported to Radiation Protocol or Safety Committee for at least three years, available for inspection.

3.1.2 An x-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic or interventional purposes unless the Agency or a QMP (QE) determines that the non-compliance shall not pose a significant radiation risk or significantly affect image quality, and arrangements have been made to correct the non-compliance within 30 days.

3.1.3 The QMP (QE), if required in this Part, shall complete initial and routine compliance evaluations following nationally recognized procedures. These evaluations shall include a review of the required QC tests.

3.1.4 All x-ray equipment shall be installed, maintained, and used in accordance with the equipment manufacturer’s specifications.

3.1.5 Individuals operating the x-ray systems shall meet the qualifications required by the Agency.

3.1.6 A sufficient number of protective apparel (e.g., aprons, gloves, collars) and shields shall be available to provide the necessary radiation protection for all patients and personnel who are involved with x-ray operations.

3.1.7 All protective apparel and auxiliary shields shall be evaluated annually for integrity and clearly labeled with their lead equivalence.

3.1.8 Each registrant should have a mechanism in place for the referring licensed practitioner to access information on selecting the most appropriate diagnostic procedure to answer the clinical question.

3.1.9 Nationally recognized diagnostic reference levels (DRLs) should be utilized when applicable.

3.1.10 The registrant shall use dose reduction strategies designed to minimize patient and personnel exposure commensurate with the needed diagnostic information.

3.1.11 Portable or mobile x-ray equipment shall be used only for examinations where it is impractical to transfer the patient to a stationary x-ray installation.

3.1.12 Neither the x-ray tube housing nor the collimating device shall be held during an exposure. An exemption or variance s is required for devices specifically designed to be hand-held, except for devices in non-human use, such as veterinary medicine or forensics.

3.1.13 The useful x-ray beam shall be limited to the area of clinical interest.

3.1.14 Consideration shall be given to selecting the appropriate technique and employing available dose reduction methods and technologies across all patient sizes and clinical indications.

3.1.15 A facility shall have a documented procedure in place for verification of patient identity and exam to be performed, including identification of the appropriate body part.

3.1.16 For general radiographic systems not equipped with an operational anatomic programming option, protocols shall be documented and readily available to the operator. At a minimum, these protocols shall include:

3.1.16.1 Patient's (adult and pediatric, if appropriate) body part and anatomical size

3.1.16.2 Technique factors

3.1.16.3 Type of image receptor used

3.1.16.4 Source to image receptor distance used (except for dental intraoral radiography)

3.1.16.5 Type of grid, if any.

3.1.17 The registrant shall create and make available to x-ray operators written safety procedures, including instructions for patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.

3.1.18 The registrant shall restrict the presence of individuals in the immediate area of the patient being examined to those required or in training for the medical procedure, or the parent or guardian of a patient while the x-ray tube is energized. The following applies to all individuals, other than the patient being examined:

3.1.18.1 All persons shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent material;

3.1.18.2 All persons shall be protected from the secondary radiation by protective garments or whole body protective barriers of not less than 0.25 millimeter lead equivalent material;

3.1.18.3 Instances may warrant having human patients other than the one being examined in the room during the exam. If the procedure results in scatter radiation in excess of 0.02 mSv (2 mR) in any one hour at the position of these patients, they shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or shall be positioned so that the 0.02 mSv (2 mR) in any one hour limit is met.

3.1.19 Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner. This provision specifically prohibits deliberate exposure for the following purposes:

3.1.19.1 Exposure of an individual for training, demonstration, or other non-healing arts purposes; and

3.1.19.2 Exposure of an individual for the purpose of healing arts screening except as authorized by the Agency.

3.1.19.3 Except under the following circumstances:

3.1.19.3.1 Exposure of an individual to the useful beam when conducting research approved by an Institutional Review Board (IRB) as allowed by Title 45, Code of Federal Regulations (CFR), Part 46 and Title 21,CFR, Part 56.

3.1.20 In cases where a patient or image receptor must be provided with auxiliary support, mechanical support devices shall be used whenever possible. If a patient or image receptor must be provided with auxiliary support during a radiation exposure:

3.1.20.1 Written safety procedures, as required by Part F, subsection 3.1.15, shall indicate the requirements for selecting a holder and the procedure the holder shall follow;

3.1.20.2 The human holder shall be instructed in personal radiation safety and protected as required by Part F, subsection 3.1.16;

3.1.20.3 No individual shall be used routinely to hold the image receptor or patient during a radiation exposure;

3.1.20.4 In those cases where the patient must hold the image receptor, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material.

3.1.21 All individuals who are associated with the operation of an x-ray system are subject to the requirements of Part D of these regulations.

3.1.22 Healing Arts Screening. Any person proposing to conduct a healing arts screening program shall not initiate such a program without prior approval of the Agency. When requesting such approval, that person shall submit the information outlined in Appendix A of Part F of these regulations. If any information submitted to the Agency becomes invalid or outdated, the Agency shall be immediately notified. FDA/MQSA-certified facilities are registered with the Agency for the use of dedicated mammographic equipment to conduct mammography screening.

3.1.23 Maintenance of Records. The registrant shall maintain the following information on each x-ray system for inspection by the Agency for a minimum of 5 years or as noted below:

3.1.23.1 Model and serial numbers of all major components, and user's manuals for those components, including software, shall be maintained for the life of the system.

3.1.23.2 Records of surveys, calibrations, maintenance, and modifications (e.g., major software and hardware upgrades) performed on the x-ray system(s); and

3.1.23.3 A copy of all correspondence with the Agency regarding the x-ray system.

3.1.24 X-Ray Utilization Record. Each facility shall maintain a record containing the patient's name, the type of examinations, and the dates the examinations were performed.

3.2 Quality Assurance.

3.2.1 The registrant shall establish and maintain a quality assurance (QA) program. In addition to the standards in the modality specific sections, the registrant shall:

3.2.1.1 Maintain documentation of minimum qualifications for practitioners, medical physicists, and x-ray equipment operators.

3.2.1.2 Designate an appropriately trained individual to manage the QA program.

3.2.1.3 Establish and maintain written QA and quality control (QC) procedures, including evaluation frequencies and tolerances.

3.2.1.4 Check each study for artifacts. If an artifact is present, the source shall be identified and appropriate action taken.

3.2.1.5 Perform repeat / reject analysis of radiographic images at least quarterly following specifications of a nationally recognized organization.

3.2.1.6 Complete preventative maintenance on the x-ray systems in accordance with manufacturer specifications at intervals not to exceed 12 months.

3.2.1.7 Maintain documentation showing the testing instruments used in determining compliance with the provisions of this section are properly calibrated and maintained in accordance with the Agency minimum standard or accepted professional standards when no Agency minimum is defined.

3.2.1.8 Complete and document an annual review of the QA program.

3.2.1.9 Retain QA/QC records of evaluations and reviews in accordance with state statutes, regulations, but in no case less than three years.

3.2.2 X-Ray Film Processing Facilities. A registrant using analog image receptors (e.g. radiographic film) shall have available suitable equipment for handling and processing radiographic film in accordance with the following provisions:

3.2.2.1 Manually developed film:

3.2.2.1.1 Processing tanks shall be constructed of mechanically rigid, corrosion resistant material; and

3.2.2.1.2 Developing solutions shall be prepared, replenished, and replaced following manufacturer recommendations.

3.2.2.1.4 Devices shall be utilized which will indicate the actual temperature of the developer solution and signal the passage of a preset time.

3.2.3 Automatic processors and other closed processing systems:

3.2.3.1 Automatic processors shall be operated and maintained following manufacturer specifications.

3.2.3.2 Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film shall be developed using the following chart:

3.2.3.3 Processing deviations from the requirements of Part F, subsection 3.2.2 shall be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing, and special rapid chemistry).

3.2.4 Additional Requirements for Facilities using X-ray Film.

3.2.4.1 Pass boxes, if provided, shall be so constructed as to exclude light from the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

3.2.4.2 Darkrooms typically used by more than one individual shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

3.2.4.3 Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.

3.2.4.4 Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary.

3.2.4.5 Outdated x-ray film shall not be used for diagnostic radiographs.

3.2.4.6 The film and intensifying screen shall be spectrally compatible.

3.2.4.7 Facilities shall maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every six months and after a change that may impact film fog.

3.2.4.8 Facilities other than dental, podiatry, and veterinary shall:

3.2.4.8.1 Have a continuous and documented sensitometric quality control program, including quality control tests for speed, contrast and fog, These tests shall be performed according to specifications of the manufacturer, a QMP (QE), or a nationally recognized organization.

3.2.4.8.2 Maintain a light-tight darkroom and use proper safelighting and safeguards such that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density from 1 to 2 when processed shall not suffer an increase in optical density greater than 0.1 when exposed in the darkroom for 2 minutes with all safelights on. If used, daylight film handling boxes shall preclude fogging of the film.

3.2.4.8.3 Limit the base plus fog of unexposed film to an optical density less than 0.25 when developed by the routine procedure used by the facility.

3.2.5 Facilities Using Computed Radiography (CR) or Direct Digital Radiography (DDR).

3.2.5.1 When exposure indicators are available, the facility shall establish and document an acceptable range for the exposure values for examinations routinely performed at the facility. The indicated exposure values for each image shall be compared to the established range. Consistent deviations from established ranges shall be investigated, corrective actions taken as necessary, and results documented.

3.2.5.2 Facilities shall establish and follow an image quality control program in accord with the recommendations of a QMP (QE), the system manufacturer, or a nationally recognized organization.

3.2.5.3 Facilities other than dental, podiatric and veterinary, shall quarterly complete phantom image evaluation using a phantom approved by a QMP (QE), system manufacturer, or the Agency. The analysis at a minimum shall include: artifacts, spatial resolution, contrast/noise, workstation monitors, and exposure indicator constancy.

3.2.5.4 In addition to Part F, subsection 3.2.4.1 through 3.2.4.3, CR facilities shall perform erasure of all CR cassettes, at least on a weekly basis.

3.3 Exemptions.

3.3.1 Dental facilities. Dental facilities performing only intra-oral, panoramic, cephalometric or volumetric dental imaging are exempt from the following provisions of this Section: Part F, subsection 3.1.8 (information available to referring physician) and Part F, subsection 3.2.1.5 (repeat analysis).

3.3.2 Podiatry facilities. Podiatry facilities are exempt from the following provisions of this Section: Part F, subsection 3.1.7 (information available to referring physician) and Part F, subsection 3.2.1.5 (repeat analysis).

3.3.3 Veterinary facilities. Veterinary facilities are exempt from the following provisions of this Section: Part F, subsection 3.1.8 (information available to referring physician), Part F, subsection 3.1.9 (use of reference levels), Part F, subsection 3.1.12 (use of dose reduction techniques), Part F, subsection 3.1.13 (patient identification), Part F, subsection 3.1.14 (protocol control), Part F, 3.1.18.3 (routine holding of patient), Part F, subsection 3.1.20 (healing arts screening), Part F, subsection 3.2.1.5 (repeat analysis), and Part F, subsection 3.2.3.8.1, (a) through (c) (use of sensitometric equipment).

4.1 In addition to other requirements of this Part, all diagnostic and interventional x ray systems shall meet the following requirements. Requirements specific to dental intra-oral, panoramic, cephalometric, volumetric dental imaging equipment are included in Part F, Section 7.0.

4.2 Warning Label.

4.2.1 On systems manufactured on or before June 10, 2006, the control panel containing the main power switch shall bear the warning statement, or the warning statement in Part F, subsection 4.2.2, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions are observed."

4.2.2 On systems manufactured after June 10, 2006, the control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."

4.3 Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (vice 100 milliroentgen (mR) exposure) in 1 hour when the x-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters (21 CFR 1020.30(k)).

4.4 Radiation from Components Other Than the Diagnostic Source Assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (vice 2 milliroentgens exposure) in 1 hour at 5 centimeters from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters. (21 CFR 1020.30(l))

4.5 Technique Indicators.

4.5.1 For x-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated. (21 CFR 1020.31(a)(1))

4.5.2 The requirement of Part F, subsection 4.5.1 may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist. (21 CFR 1020.31(a)(1))

4.5.3 The accuracy of the indicated kilovoltage peak (kVp) shall meet manufacturer specifications. In the absence of a manufacturer specification, kVp accuracy shall be within +10 percent.

4.6 Beam Quality.

4.6.1 The half value layer (HVL) of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 1. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table 1 of this section, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. (21 CFR 1020.30(m)) In the case of a system, which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent x-ray emissions if the minimum required filtration is not in place. (21 CFR 1020.30)

TABLE 1

(21 CFR 1020.30(m))

4.6.2 Optional filtration on fluoroscopic systems. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube(s) with a continuous output of 1 kilowatt or more and an anode heat storage capacity of 1 million heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions of this subsection. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided. (21 CFR 1020.30(m)(2))

4.6.3 Measuring compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.

4.7 Aluminum equivalent of material between patient and image receptor. Except when used in a CT x-ray system, the aluminum equivalent of each of the items listed in Table 2 in this paragraph, which are used between the patient and the image receptor, may not exceed the indicated limits. Compliance shall be determined by x-ray measurements made at a potential of 100 kilovolts peak and with an x-ray beam that has an HVL specified in Table 1 of this section for the potential. This requirement applies to front panel(s) of image receptors and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids.

TABLE 2

4.8 Battery charge indicator. On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

4.9 Modification of certified diagnostic x-ray components and systems.

4.9.1 Diagnostic x-ray components and systems certified in accordance with 21 CFR Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this Part.

4.9.2 The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this Part. The owner who causes such modification need not submit the reports required by this Part, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with this Part.

4.10 Multiple Tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube which has been selected shall be clearly indicated prior to initiation of the exposure. Only the selected tube can be energized. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.

4.11 Mechanical Support of Tube Head. The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.

4.12 Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.

4.13 Maintaining Compliance. Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in compliance with applicable requirements of that standard.

5.1 The provisions of this Part apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor. (21 CFR 1020.32)

5.2 Only image-intensified or direct-digital receptor fluoroscopic equipment shall be used for fluoroscopy.

5.3 Primary Protective Barrier.

5.3.1 Limitation of useful beam. The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor shall not exceed 3.34x10-3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation. (21 CFR 1020.32(a)(1))

5.3.2 Measuring compliance. The AKR shall be measured in accordance with Part F, subsection 5.6. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm. Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly. (21CFR 1020.32(a)(2)).

5.4 Field Limitation.

5.4.1 Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with Part F, subsection 5.4.5 and Part F, subsection 5.4.6 shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. (21 CFR 1020.32(b)(1))

5.4.2 Further means for limitation. Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of Part F, subsection 5.4.5 and Part F, subsection 5.4.6 Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or capability of a visible area of greater than 300 cm2, shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 cm2 shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to 125 cm2 or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of 5 cm by 5 cm. (21 CFR 1020.32(b)(2))

5.4.3 Spot-film devices. In addition to applicable regulations in Part F, Section 6.0 (Radiographic Equipment), the following requirements shall apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system: (21 CFR 1020.31(h))

5.4.3.1 Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation. (21 CFR 1020.31(h)(1))

5.4.3.2 Neither the length nor width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3 percent of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4 percent of the SID. On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. (21 CFR 1020.31(h)(2))

5.4.3.3 The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2 percent of the SID. (21 CFR 1020.31(h)(3))

5.4.3.4 Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that: (21 CFR 1020.31(h)(4))

5.4.3.4.1 For spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or (21 CFR 1020.31(h)(4)(i))

5.4.3.4.2 For spot-film devices used on fluoroscopic systems that have a variable SID and/or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of 5 cm by 5 cm. (21 CFR 1020.31(h)(4)(ii))

5.4.4 A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist’s position shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:

For X-ray Field Limitation System Failure

(21 CFR 1020.31(h)(5))

5.4.5 Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.

5.4.5.1 For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies: (21 CFR 1020.32(b)(4)(i)

5.4.5.1.1 Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID. (21 CFR 1020.32(b)(4)(i)(A))

5.4.5.1.2 For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor. (21 CFR 1020.32(b)(4)(i)(B))

5.4.5.2 For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one of the following requirements: (21 CFR 1020.32(b)(4)(ii))

5.4.5.2.1 When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 cm in any direction, at least 80 percent of the area of the x-ray field overlaps the visible area of the image receptor, or (21 CFR 1020.32(b)(4)(ii)(A))

5.4.5.2.2 When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 cm in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than 2 cm. (21 CFR 1020.32(b)(4)(ii)(B))

5.4.6 Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies: (21 CFR 1020.32(b)(5))

5.4.6.1 Neither the length nor width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID. (21 CFR 1020.32(b)(5)(i))

5.4.6.2 The error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor. (21 CFR 1020.32(b)(5)(ii))

5.4.7 Override capability. If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist’s position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:

FOR X-RAY FIELD

LIMITATION SYSTEM FAILURE

(21 CFR 1020.32(b)(6))

5.5 Activation of Tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process. (21 CFR 1020.32(c))

5.6 Air Kerma Rates. For fluoroscopic equipment, the following requirements apply:

5.6.1 Fluoroscopic equipment manufactured before May 19, 1995.

5.6.1.1 Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.4 except as specified in Part F, subsection 5.6.1.5. (21 CFR 1020.32(d)(1)(i))

5.6.1.2 Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.5, except as specified in Part F, subsection 5.6.1.5. (21 CFR 1020.32(d)(1)(ii))

5.6.1.3 Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) in either mode at the measurement point specified in Part F, subsection 5.6.4, except as specified in Part F, subsection 5.6.1.5 (21 CFR 1020.32(d)(1)(iii))

5.6.1.4 Equipment may be modified in accordance with this Part to comply with Part F, subsection 5.6.2. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

MODIFIED TO COMPLY WITH 21 CFR 1020.32(H)(2)

(21 CFR 1020.32(d)(1)(iv))

5.6.1.5 Exceptions: During recording of fluoroscopic images.

5.6.2 Fluoroscopic equipment manufactured on or after May 19, 1995.

5.6.2.1 Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.4. Provision for manual selection of technique factors may be provided. (21 CFR 1020.32(d)(2)(i))

5.6.2.2 Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.4, except as specified in Part F subsection 5.6.2.3. (21 CFR 1020.32(d)(2)(ii))

5.6.2.3 Exceptions:

5.6.2.3.1 For equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode. (21 CFR 1020.32(d)(2)(iii)(A))

5.6.2.3.2 For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded. (21 CFR 1020.32(d)(2)(iii)(B))

5.6.3 Fluoroscopy equipment with optional high-level control

5.6.3.1 When high-level control is selected and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure rate) at the measurement point specified in Part F, subsection 5.6.4. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is employed.

5.6.4 Measuring compliance. Compliance with this subsection shall be determined as follows:

5.6.4.1 If the source is below the x-ray table, the AKR shall be measured at 1 cm above the tabletop or cradle. (21 CFR 1020.32(d)(3)(i))

5.6.4.2 If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. (21 CFR 1020.32(d)(3)(ii))

5.6.4.3 In a C-arm type of fluoroscope, the AKR shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly. (21 CFR 1020.32(d)(3)(iii))

5.6.4.4 In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD. (21 CFR 1020.32(d)(3)(iv))

5.6.4.5 In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table. (21 CFR 1020.32(d)(3)(v))

5.6.5 Exemptions. Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in Part F, subsection 5.6 when used for therapy simulation purposes. (21 CFR 1020.32(d)(4))

5.7 Indication of potential and current. During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated value shall not exceed the maximum deviation as stated by the manufacturer. (21 CFR 1020.32(f))

5.8 Source-skin distance.

5.8.1 Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical or interventional applications that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operating at shorter source-skin distances but in no case less than 20 cm.

5.8.2 For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical that would be prohibited at the source-skin distance specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm.

5.9 Fluoroscopic irradiation time, display, and signal.

5.9.1 Fluoroscopic equipment manufactured before June 10, 2006:

5.9.1.1 Shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 CFR 1020.30(q) to comply with the requirements of this paragraph. When the equipment is modified, it shall bear a label indicating the statement:

Modified to comply with 21 CFR 1020.32(h)(2)

(21 CFR 1020.32(h)(1)(i))

5.9.1.2 As an alternative to the requirements of this paragraph, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations. (21 CFR 1020.32(h)(1)(ii))

5.9.2 For x-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:

5.9.2.1 A display of the fluoroscopic irradiation time at the fluoroscopist’s working position. This display shall function independently of the audible signal described in this subsection. The following requirements apply: (variation of 21 CFR 1020.32(h)(2)(i))

5.9.2.1.1 When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every 6 seconds. (21 CFR 1020.32(h)(2)(i)(A))

5.9.2.1.2 The fluoroscopic irradiation time shall also be displayed within 6 seconds of termination of an exposure and remain displayed until reset. (21 CFR 1020.32(h)(2)(i)(B))

5.9.2.1.3 Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure. (21 CFR 1020.32(h)(2)(i)(C))

5.9.2.2 A signal audible to the fluoroscopist shall sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least 2 seconds. (21 CFR 1020.32(h)(2)(ii))

5.10 Display of last-image-hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure. (21 CFR 1020.32(j))

5.10.1 For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure. (21 CFR 1020.32(j)(1))

5.10.2 For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure. (21 CFR 1020.32(j)(2))

5.10.3 Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images. (21 CFR 1020.32(j)(3))

5.11 Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist’s working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure: (21 CFR 1020.32(k))

5.11.1 When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second. (21 CFR 1020.32(k)(1))

5.11.2 The cumulative air kerma in units of mGy shall be displayed either within 5 seconds of termination of an exposure or displayed continuously and updated at least once every 5 seconds. (21 CFR 1020.32(k)(2))

5.11.3 The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma. (21 C FR 1020.32(k)(3))

5.11.4 The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope. (21 CFR 1020.32(k)(4))

5.11.4.1 For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference location shall be the respective locations specified in Part F, subsection 5.6.4.1, 5.6.4.2 or 5.6.4.5 (21 CFR 1020.32(k)(4)(i))

5.11.4.2 For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient’s skin. (21 CFR 1020.32(k)(4)(ii))

5.11.5 Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure. (21 CFR 1020.32(k)(5))

5.11.6 The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ±35 percent over the range of 6 mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than 3 seconds. (21 CFR 1020.32(k)(6))

5.12 Protection From Scatter Radiation.

5.12.1 For stationary fluoroscopic systems, ancillary shielding, such as drapes, self-supporting curtains, or viewing shields, shall be available and used as supplemental protection for all individuals other than the patient in the room during a fluoroscopy procedure.

5.12.1.2 Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met.

5.12.1.2.1 Shielding required under Part F, subsection 5.12.1 shall be maintained to the degree possible under the clinical conditions.

5.12.1.2.2 All persons, except the patient, in the room where fluoroscopy is performed shall wear protective aprons that provide a lead equivalent shielding of at least 0.25 mm.

5.12.1.2.3 The fluoroscopic field size shall be reduced to the minimum required for the procedure being performed (area of clinical interest).

5.12.1.2.4 Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use and/or non-use of the protective drapes.

5.13 Operator Qualifications.

5.13.1 In addition to the applicable sections of these regulations, the operation of a fluoroscopic x-ray system for clinical purposes shall be limited to:

5.13.1.1 A state licensed practitioner, or certified radiologic technologist working within his or her scope of practice;

5.13.1.2 A Radiologist Assistant (RA) (if recognized by the state licensing agency) working within his or her scope of practice and under the direct supervision of a licensed practitioner meeting the conditions of Part F, subsection 5.13.1.1;

5.13.1.3 A state-licensed physician’s assistant who passed the state-level American Registry of Radiologic Technologists (ARRT) Fluoroscopy Exam (or equivalent) and only under the direct supervision of the licensed practitioner meeting the conditions of Part F, subsection 5.13.1.1. This operator qualification is limited to physician’s assistants, and excludes nurse practitioners.

5.13.1.4 A medical resident or radiologic technology student, in training, and only under the personal supervision of the licensed practitioner meeting the conditions of Part F, subsection 5.13.1.1.

5.13.2 All persons operating, or supervising the operation of, fluoroscopy systems shall have completed training that includes but is not limited to the following:

5.13.2.1 Basic properties of radiation;

5.13.2.2 Biological effects of x-ray;

5.13.2.3 Radiation protection methods for patients and staff;

5.13.2.4 Units of measurement and dose, including DAP (dose-area product) values & air kerma;

5.13.2.5 Factors affecting fluoroscopic outputs;

5.13.2.6 High level control options;

5.13.2.7 Dose management including dose reduction techniques, monitoring, and recording;

5.13.2.8 Principles and operation of the specific fluoroscopic x-ray system(s) to be used;

5.13.2.9 Fluoroscopic and fluorographic outputs of each mode of operation on the system(s) to be used clinically; and

5.13.2.10 Applicable requirements of these regulations.

5.13.3 All persons operating, or supervising the operation of, fluoroscopy systems during Fluoroscopically Guided Interventional (FGI) procedures shall have completed training that includes but is not limited to:

5.13.3.1 The topics provided in Part F, subsection 5.13.2;

5.13.3.2 Methods to reduce patient dose using advanced imaging and recording features;

5.13.3.3 Procedures for recording pertinent data specified in Part F, subsection 5.16, and

5.13.3.4 Documentation pertaining to the requirements of Part F, Section 5.0 shall be maintained for review for three years.

5.14 Equipment Operation.

5.14.1 All fluoroscopic images shall be viewed, directly or indirectly, and interpreted by a licensed practitioner working within their scope of practice.

5.14.2 Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

5.14.3 Operators shall be competent in the standard operating procedures of the unit in use, including the use of available dose-saving features, and the relative radiation output rates of the various modes of operation.

5.14.4 Procedure planning for fluoroscopic procedures on pregnant patients shall include feasible modifications to minimize the dose to the conceptus.

5.14.5 Procedure planning for fluoroscopic procedures on pediatric patients shall include feasible modifications to minimize dose.

5.14.6 The registrant shall use all methods available on the fluoroscopy system to monitor dose during a fluoroscopic procedure.

5.14.7 The facility shall establish a written policy regarding patient dose management in fluoroscopically guided procedures in conformance with the ACR-AAPM Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (ACR Resolution 44 – 2013), NCRP Report 168, or equivalent.

5.15 Qualified Medical Physicist Evaluations.

5.15.1 Fluoroscopic equipment shall be evaluated by a QMP within 30 days of installation. Any maintenance of the system that may affect the exposure rate shall be evaluated by a QMP, or internally authorized staff under the general direction of a QMP. Thereafter, the measurements shall be made of fluoroscopic equipment annually. At a minimum these evaluations shall include:

5.15.1.1 A measurement of entrance exposure rates that covers the full range of patient thicknesses, including those that are expected to drive the system to maximum output in all modes clinically used, including fluoroscopy, high-level control, acquisition, digital subtraction and Cineradiography, when available. These measurements shall:

5.15.1.1.1 For systems without automatic exposure control, be made utilizing a milliamperage and kVp typical of the clinical use of the fluoroscopic system;

5.15.1.1.2 For systems with automatic exposure control, be made utilizing sufficient attenuating material in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system;

5.15.1.2 A measurement and verification of compliance of maximum AKR for fluoroscopy and high-level control, if available. Measurements shall be made in accordance with Part F, subsection 5.6.4.

5.15.1.3 An evaluation of high contrast resolution and low contrast resolution in both fluoroscopic and spot-film modes.

5.15.1.4 An evaluation of the operation of the 5-minute timer, warning lights, interlocks, and collision sensors.

5.15.1.5 An evaluation of the beam quality and collimation in the fluoroscopy and spot-film modes.

5.15.1.6 An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.

5.15.1.7 An evaluation of any changes that may impact patient and personnel protection devices.

5.15.2 Measurements required in Part F, subsection 5.15.1 shall be performed with a calibrated dosimetry system per manufacturer recommendations not to exceed 2 years and records maintained for 5 years for inspection by the Agency.

5.16 Additional requirements for facilities performing fluoroscopically-guided interventional (FGI) procedures.

5.16.1 A registrant utilizing FGI procedures shall establish a Radiation Protocol Committee (RPC) in accordance with the following.

5.16.1.1 The registrant may establish a system-wide committee if the registrant has more than one site.

5.16.1.2 Two or more registrants may form a cooperative RPC as long as each facility has a representative on the committee.

5.16.1.3 If the registrant has already established a radiation safety committee, the requirements of this subsection may be delegated to that committee if the members meet the requirements of Part F, subsection 5.16.5.

5.16.2 A quorum of the RPC shall meet as often as necessary, but at intervals not to exceed 12 months.

5.16.3 Record of RPC. A record of each RPC meeting shall include the date, names of individuals in attendance, minutes of the meeting, and any actions taken. The registrant shall maintain RPC meeting record for inspection by the Agency for at least three years.

5.16.4 Provide an annual report to the radiation safety committee, or to the radiation safety officer.

5.16.5 RPC Members. Members shall include but not be limited to the following individuals:

5.16.5.1 A supervising licensed practitioner of the healing arts who meets the requirements in Part F, subsection 5.13;

5.16.5.2 A QMP or QE;

5.16.5.3 A radiologic technologist; and

5.16.5.4 Other individuals as deemed necessary by the registrant. (eg. RSO, Chief Medical or Administrative Officer, Radiology Department Administrator/Manager)

5.16.6 Establish and implement FGI procedure protocols.

5.16.6.1 The RPC shall establish and implement written protocols, or protocols documented in an electronic report system, that include but are not limited to the following:

5.16.6.1.1 A method to be used to monitor patient radiation dose during FGI.

5.16.6.1.2 Dose notification levels, as appropriate, at which the physician is notified and appropriate actions are taken for patient safety.

5.16.6.1.3 Substantial Radiation Dose Level (SRDL) values following nationally recognized standards,

5.16.6.1.4 Actions to be taken for cases when a SRDL is exceeded which may include patient follow-up.

5.16.6.1.5 A review of the established protocols at an interval not to exceed 12 months.

5.16.6.2 A record of each RPC protocol shall be maintained for inspection by the Agency.

5.16.7 Procedures for maintaining records.

5.16.7.1 A record of radiation output information shall be maintained so the radiation dose to the skin may be estimated in accordance with established protocols. The record shall include the following:

5.16.7.1.1 Patient identification;

5.16.7.1.2 Type and date of examination;

5.16.7.1.3 Identification of the fluoroscopic system used; and

5.16.7.1.4 Peak skin dose, cumulative air kerma or dose area product used if the information is available on the fluoroscopic system.

5.16.7.1.5 If the peak skin dose, cumulative air kerma or dose area product are not displayed on the fluoroscopic system, records shall include other information necessary to estimate the radiation dose to the skin in accordance with established protocol or the following as necessary:

5.16.7.1.5.1 Fluoroscopic mode, such as, high-level or pulsed mode of operation;

5.16.7.1.5.2 Cumulative fluoroscopic exposure time; and

5.16.7.1.5.3 Number of films or recorded exposures.

5.16.7.2 The registrant shall maintain records required by this subparagraph for inspection by the Agency.

6.1 The following regulations apply to all non-dental registrants using diagnostic x-ray equipment. Requirements specific to using dental intra-oral, hand held, panoramic, and cephalometric equipment are in Part F, Section 7.0.

6.2 Digital radiographic systems shall be evaluated by a QMP (QE) prior to clinical use, and at least annually. The evaluation shall follow nationally recognized standards or procedures. Unless otherwise specified in this Part, dental, podiatric, and veterinary systems are exempt from this requirement.

6.3 Control and indication of technique factors.

6.3.1 Timers. Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. (21 CFR 1020.31(a)(2))

6.3.1.1 Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero. It shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided. (21 CFR 1020.31(a)(2)(i))

6.3.1.2 During serial radiography, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process. (21 CFR 1020.31(a)(2)(ii))

6.3.2 Automatic exposure controls. When an automatic exposure control is provided:

6.3.2.1 Indication shall be made on the control panel when this mode of operation is selected; (21 CFR 1020.31(a)(3)(i))

6.3.2.2 When the x-ray tube potential is equal to or greater than 51 kilovolts peak (kVp), the minimum exposure time for field emission equipment rated for pulse operation shall be equal to or less than a time interval equivalent to two pulses and the minimum exposure time for all other equipment shall be equal to or less than 1/60 second or a time interval required to deliver 5 milliampere-seconds (mAs), whichever is greater; (21 CFR 1020.31(a)(3)(ii))

6.3.2.3 Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 kilowatt-seconds (kWs) per exposure or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure, except when the x-ray tube potential is less than 51 kVp, in which case the product of x-ray tube current and exposure time shall be limited to not more than 2,000 mAs per exposure; and (21 CFR 1020.31(a)(3)(iii))

6.3.2.4 A visible signal shall indicate when an exposure has been terminated at the limits described in Part F, subsection 6.3.2.3, and manual resetting shall be required before further automatically timed exposures can be made. (21 CFR 1020.31(a)(3)(iv))

6.3.3 Accuracy. Deviation of technique factors under Part F, subsection 6.3 from indicated values shall not exceed the limits given by the manufacturer. (variation of 21 CFR 1020.31(a)(4))

6.4 Reproducibility.

6.4.1 Coefficient of variation. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than 0.05. (21 CFR 1020.31(b)(1)