Radiation Safety Plan Supplement

Excerpts from COMAR 26.12.01.01

Part B
Registration of Radiation Machine Facilities and Services

Sec. B.1 Purpose and Scope

This Part provides for the registration of radiation machine facilities and for the registration of persons providing radiation machine installation, servicing, and/or services.
In addition to the requirements of this part, all registrants are subject to the applicable provisions of other parts of these regulations.

Sec. B.2 Definitions

Facility means the location at which one or more devices or sources are installed and/or located within one building, vehicle, or under one roof and are under the same administrative control.

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 by a person registered under Sec. B.6 of this Part.

Sec. B.3 Exemptions

Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this Part, provided that the dose equivalent rate 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.
Radiation machines while in transit or storage incident thereto are exempt from the requirements of this Part.
Domestic television receivers are exempt from the requirements of this Part.

Sec. B.4 Shielding Plan Review

At least 14 days prior to installation or relocation of a radiation machine intended for use for diagnostic or therapeutic purposes, the floor plans, shielding specifications and equipment arrangement of this installation or relocation shall be submitted to the Agency for review and approval on forms provided by the Agency. Appendix A is provided as a guide for the proper design of an operators booth.
After January 19, 1987, structural shielding design shall be performed by a person currently registered with the agency under this Part.
The approval of such 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 Part D of these regulations.
After installation of a radiation machine, the registrant shall maintain for inspection by the Agency:
1. The maximum rated technique factors of each x-ray system control panel;
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:
1. the results of a survey for radiation present at the operator's position and at pertinent points outside the room at specified test conditions, or
2. the type and thickness of materials, or lead equivalency, and of each protective barrier.

Sec. B.5 Registration of Radiation Machine Facilities

Each person having a radiation machine facility shall:

Apply for registration of such facility with the Agency prior to the completion of the installation of a radiation machine in the 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.
Designate on the application form an individual to be responsible for radiation protection.
Prohibit any person from furnishing radiation machine servicing or services as described in B.6(d) to his radiation machine facility until such person provides evidence that he has been registered with the Agency as a provider of services in accordance with B.6.

Sec. B.6 Application for Registration of Servicing and Services

Each person 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 prior to furnishing or offering to furnish any such services.
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.
Each person applying for registration under this part shall specify:
1. that he has read and understands the requirements of these regulations;
2. the services for which he is applying for registration;
3. the training and experience that qualify him to discharge the services for which he is applying for registration;
4. the type of measurement instrument to be used, frequency of calibration, and source of calibration; and
5. the type of personnel dosimeters supplied, frequency of reading, and replacement or exchange schedule.
For the purpose of B.6, services may include but shall not be limited to:
1. installation and/or servicing of radiation machines and associated radiation machine components,
2. calibration of radiation machines or radiation measurement instruments or devices,
3. radiation protection or health physics consultations or surveys, and
4. personnel dosimetry services.
No individual shall perform services which are not specifically stated for that individual on the notice of registration issued by the Agency.
A license granted by the State under COMAR 26.12.02.03 shall constitute registration under this Part.

Sec. B.7 Issuance of Notice of Registration

Upon a determination that an applicant meets the requirements of the regulations, the Agency shall issue a notice of registration.
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 possession, use, transfer, or servicing of radiation machines as it deems appropriate or necessary.

Sec. B.8 Expiration of Notice of Registration

Except as provided by B.9(b), each notice of registration shall expire at the end of the specified day in the month and year stated therein.

Sec. B.9 Renewal of Notice of Registration

Application for renewal of registration shall be filed in accordance with B.5 or B.6.
In any case in which a registrant not less than 14 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.

Sec. B.10 Report of Changes

The registrant shall notify the Agency in writing before making any change which would render the information contained in the application for registration and/or the notice of registration no longer accurate.

Sec. B.11 Approval Not Implied

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 B.5 or B.6, and no person shall state or imply that any activity under such registration has been approved by the Agency.

Sec. B.12 Assembler and/or Transfer Obligation

Any person who sells, leases, transfers, lends, disposes, assembles, or installs radiation machines in this State shall notify the Agency within 15 days on forms provided by the Agency of the following:
1. The present and previous machine location; and
2. The manufacturer, model, date of manufacture and other general information required by the form.
No person shall make, sell, lease, transfer, lend, assemble, or Install radiation machines 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.

Part F
X Rays in the Healing Arts

Sec. F.1 Scope
This part establishes requirements, for which a registrant is responsible, for use of 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 these regulations.

Sec. F.2 Definitions
As used in this part, the following definitions apply:
Accessible surface means the external surface of the enclosure or housing provided by the manufacturer.
Added filtration means any filtration which is in addition to the inherent filtration.
Aluminum equivalent means the thickness of type 1100 aluminum alloy 1/ affording the same attenuation, under specified conditions, as the material in question.
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 1/ or other materials having equivalent attenuation.
Automatic exposure control 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 (See also Phototimer).
Barrier (See Protective barrier).
Beam axis means a line from the source through the centers of the x-ray fields.
1/ The nominal chemical composition of type 1100 aluminum alloy is 99.00 percent minimum aluminum, 0.12 percent copper.
Beam-limiting device means a device which provides a means to restrict the dimensions of the x-ray field.
Beam monitoring system means a system designed to detect and measure the radiation present in the useful beam.
Cephalometric device means a device intended for the radiographic visualization and measurement of the dimensions of the human head.
Certified components means components of x-ray systems which are subject to regulations promulgated under Public Law 90-602, the Radiation Control for Health and Safety Act of 1968.
Certified system means any x-ray system which has one or more certified component(s).
Changeable filters means any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process.
Coefficient of variation or C means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:
Rough Equation

C HORZ 100 = HORZ 100 s Over Overline x HORZ 100 = HORZ 100 1 Over Overline x Horz 100 Left [Sum From {i = 1} TO n { (xSub i Overline x)SUP 2} over {n1} Right ] SUP {1/2}
where
s = Estimated standard deviation of the population.
X = Mean value of observations in sample.
X_i = ith observation in sample.
n = Number of observations in sample.

Computed tomography means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.
Contact therapy system means an x-ray system used for therapy with the x-ray tube port placed in contact with or within 5 centimeters of the surface being treated.
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.
CT (See Computed tomography).
Dead-man switch means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator. 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 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).
Entrance exposure rate means the exposure per unit time at the point where the center of the useful beam enters the patient.
Equipment (See X-ray equipment).
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 absorb preferentially selected radiations.
Fluoroscopic imaging assembly means a subsystem in which x-ray photons produce a fluoroscopic image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
Focal spot means the area projected on the anode of the x-ray tube 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 means the thickness of specified material which attenuates the beam of radiation to an extent such that the exposure rate is reduced to 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.
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 energy density.
Image receptor means any device, such as a fluorescent screen or radiographic film, 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.
Image receptor support means, for mammographic systems, that part of the system designed to support the image receptor in a horizontal plane during a mammographic examination.
Inherent filtration means the filtration of the useful beam provided by the permanently installed components of the tube housing assembly.
Irradiation means the exposure of matter to ionizing radiation.
Kilovolts peak (See Peak tube potential).
kV means kilovolts.
kVp (See Peak tube potential).
kWs means kilowatt second. It is equivalent to 103 kV.mA.s, i.e.,
(A)kWs = (X)kV x (Y)mA x (Z)s x kWs = XYZ kWs
103kV x mA x s 103
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 or therapeutic 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 or therapeutic 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, i.e., 10 milliampere seconds, 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 or therapeutic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential.
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.
Linear attenuation coefficient or µ means the quotient of dN/N divided by dl when dN/N is the fraction of uncharged ionizing radiation that experience interactions in traversing a distance dl in a specified material.
Line-voltage regulation means the difference between the no-load and the load line potentials expressed as a percent of the load line potential. It is calculated using the following equation:
Percent line-voltage regulation = 100 (V_n-V_l)/V_l
where
V_n = No-load line potential and
V_l = Load line potential.
mA means milliampere.
mAs means milliampere second.
Maximum line current means the root-mean-square current in the supply line of an x-ray machine operating at its maximum rating.
Mobile x-ray equipment (See X-ray equipment).
Patient means an individual subjected to healing arts examination, diagnosis, or treatment.
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.
Phototimer means a method for controlling radiation exposures to image receptors by the amount of radiation which reaches a radiation monitoring device(s). The radiation monitoring device(s) is part of an electronic circuit which controls the duration of time the tube is activated (See Automatic exposure control).
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.
Primary dose monitoring system means a system which will monitor the useful beam during irradiation and which will terminate irradiation when a pre-selected number of dose monitor units have been acquired.
Primary protective barrier (See Protective barrier).
Protective apron means an apron made of radiation absorbing materials used to reduce radiation exposure.
Protective barrier means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:
1. Primary protective barrier means the material, excluding filters, placed in the useful beam, for protection purposes, to reduce the radiation exposure.
2. Secondary protective barrier means a barrier sufficient to attenuate the stray radiation to the required degree.
Protective glove means a glove made of radiation absorbing materials used to reduce radiation exposure.
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.
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.
Radiographic imaging system means any system whereby a permanent or semi-permanent image is recorded on an image receptor by the action of ionizing radiation.
Radiological physicist means an individual who,
1. is certified by the American Board of Radiology in therapeutic radiological physics, radiological physics, or x- and gamma-ray physics; or
2. has a bachelor's degree in one of the physical sciences or engineering and three years full-time experience working in therapeutic radiological physics under the direction of a physicist certified by the American Board of Radiology. The work duties shall include duties involving the calibration and spot checks of a medical accelerator or a sealed source teletherapy unit; or
3. has a Master's or a Doctor's degree in physics, biophysics, radiological physics, health physics, or engineering; has had 1 year's full-time training in therapeutic radiological physics; and has had 1 year's full-time work experience in a radiotherapy facility where the individual's duties involve calibration and spot checks of a medical accelerator or a sealed source teletherapy unit.
Rating means the operating limits as specified by the component manufacturer.
Recording means producing a permanent form of an image resulting from x-ray photons.
Response time means the time required for an instrument system to reach 90 percent of its final reading when the radiation-sensitive volume of the instrument system is exposed to a step change in radiation flux from zero sufficient to provide a steady state midscale reading.
Scattered radiation means radiation that, during passage through matter, has been deviated in direction (See Direct scattered radiation).
Secondary dose monitoring system means a system which will terminate irradiation in the event of failure of the primary system.
Secondary protective barrier (See Protective barrier).
Shutter means a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
SID (see Source-image receptor distance).
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.
Spot check means a procedure which is performed to assure that a previous calibration continues to be valid.
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 an image intensifier for the purpose of making a radiograph.
SSD means the distance between the source and the skin of the patient.
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 kV and quantity of charge in mAs;
2. For field emission equipment rated for pulsed operation, peak tube potential in kV, and number of x-ray pulses;
3. For CT x-ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in 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 x-ray systems 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.
Termination of irradiation means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
Tomogram means the depiction of the x-ray attenuation properties of a section through the body.
Traceable to a national standard means that a quantity or a measurement has been compared to a national standard directly or indirectly through one or more intermediate steps and that all comparisons have been documented.
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 emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the system to produce radiation.
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.
Wedge filter means an added filter effecting continuous progressive attenuation on all or part of the useful beam.
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.
3. Stationary x-ray equipment means x-ray equipment which is installed in a fixed location, and includes x-ray equipment permanently installed in a vehicle.
X-ray field means that area of the intersection of the useful beam and any 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 exposure rate 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.
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 tube means any electron tube which is designed to be used primarily for the production of x rays.

Sec. F.3 General Requirements
1. Administrative Controls.
  1. Registrant. The registrant shall be responsible for directing the operation of the x-ray system(s) under his administrative control. The registrant or the registrant's agent shall assure that the requirements of these regulations are met in the operation of the x-ray system(s).
    1. An x-ray system which does not meet the provisions of these regulations shall not be operated for diagnostic or therapeutic purposes.
    2. Individuals who will be operating the x-ray systems shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment.
    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:
      1. patient's body part and anatomical size or body part thickness, or age (for pediatrics) versus technique factors to be utilized;
      2. type and size of the film or film-screen combination to be used;
      3. type and focal distance of the grid to be used, if any;
      4. source to image receptor distance to be used;
      5. type and location of placement of patient shielding (e.g., gonad, etc.) to be used; and
      6. for mammography, indication of kVp/target/filter combination.
    4. Written safety procedures shall be provided to each individual operating x-ray equipment, including 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.
    5. Except for patients who cannot be moved out of the room, only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic exposure. Other than the patient being examined:
      1. All individuals shall be positioned such that no part of the body will be struck by a useful beam unless protected by no less than 0.5 millimeter lead equivalent.
      2. All persons 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.
      3. 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 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.
    6. Gonad shielding of not less than 0.5 millimeter lead equivalent shall be used for 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.
    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 also prohibits deliberate exposure for the purpose of training, demonstration, or other non-healing-arts purposes.
    8. When a patient or film must be provided with auxiliary support during a radiation exposure:
      1. mechanical holding devices shall be used when the technique permits. The written safety procedures, required by F.3(a)(1)(iv), shall list individual projections where holding devices cannot be utilized;
      2. written safety procedures, as required by F.3(a)(l)(iv), shall indicate the requirements for selecting a holder and the procedure the holder shall follow;
      3. the human holder shall be protected as required by F.3(a)(1)(v);
      4. no individual shall be used routinely to hold film or patients; and
      5. in those cases where the patient must hold the film, 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.
      6. the beam defining light, if present, shall be turned on during all exposures for which a human holder is used. The operator shall not initiate the exposure except on permission from the holder.
    9. Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized. Such procedures and equipment shall include, but are not limited to the following:
      1. The speed of film or screen and film combinations shall be the fastest speed consistent with the diagnostic objective of the examinations;
      2. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality;
      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; or
      4. X-ray systems subject to F.6 shall not be utilized in procedures where the source to patient distance is less than 30 centimeters.
    10. All individuals who are associated with the operation of an x-ray system are subject to the requirements of D.101, D.102, and D.202 of these regulations. In addition:
      1. When protective clothing or devices are worn on portions of the body and a personnel monitoring device(s) is required, at least one such monitoring device shall be utilized as follows:
        When an apron is worn, the monitoring device shall be worn at the collar outside of the apron.
        The dose to the whole body based on the maximum dose attributed to the most critical organ shall be recorded in the reports required by D.401 of these regulations. If more than one device is used and a record is made of the data, each dose shall be identified with the area where the device was worn on the body.
      2. Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.
  2. Maintenance Records and Associated Information.
    The registrant shall maintain the following information for each x-ray system for inspection by the Agency:
    1. maximum rating of technique factors;
    2. model and serial numbers of all certifiable components;
    3. aluminum equivalent filtration of the useful beam, including any routine variation;
    4. tube rating charts and cooling curves;
    5. records of surveys, calibrations, maintenance, and effective modifications performed on the x-ray system(s) after the effective date of F.3 with the names of persons who performed such services;
    6. a scale drawing of the room in which a stationary x-ray 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:
      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
      2. a copy of the plan review submitted to the Agency under B.4 and the Agency's letter of approval.
    7. a copy of all correspondence with this Agency regarding that x-ray system.
  3. X-Ray Log.
    Each facility shall maintain an x-ray log 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 shall be recorded.
2. Processing of film.
  1. All film shall be processed in such a fashion as to achieve adequate sensitometric performance. "Adequate sensitometric performance" means a measured processing speed of:
    1. Greater than or equal to 80, and
    2. Less than or equal to 120; as measured by the Sensitometric Technique for the Evaluation of Processing (STEP) test [1/].
  2. Manual Processing of Film.
    1. Where film is developed manually, a system shall be available which consists of at least one three-sectional tank made of mechanically rigid, corrosion resistant material (each section of which shall be constructed so as to retain its solution separate from the other two) and has the overall temperature controlling capability of maintaining each solution such that the temperature of each solution will always fall within the range of 60°F to 80° (16-27°C).
    2. Devices shall be available which will:
      1. Give the actual temperature of the developer, plus or minus 2°F (or 1°C if SI units are used), and
      2. Give an audible or visible signal after a preset time, plus or minus 10% of the present time.
  3. Chemical-Film Processing Control.
    1. Chemicals shall be mixed in accord with the chemical manufacturer's recommendations.
    2. Developer replenisher shall be periodically added to the developer tank based on the area of the films which have been developed (e.g., 1 liter per 3100 in2 of film or in accord with the recommendation of the chemical
      1/This test is described by Suleiman, O.H. et al. in the article "Automatic Film Processing: Analysis of 9 Years of Observations." Radiology 1992 Vol. 185, pp. 25-28.
      manufacturer). Solution may be removed from the tank to permit the addition of an adequate volume of replenisher.
    3. All processing chemicals shall be completely replaced at least every 3 months.
  4. Automatic Processors and Other Closed Processing System
    Preventive maintenance shall be performed on the unit, except for extended periods of non-use, on a frequency basis which is not less than that schedule recommended by the manufacturer. In the event that no schedule is available from the manufacturer, a maintenance schedule shall be established which will preserve good film quality.
  5. Film Fog Prevention
    1. Film processing areas and devices shall be constructed so that film being processed, handled, or stored will be exposed only to light which has passed through a proper safelight filter.
    2. That light which remains in a film processing area or device following compliance with F.3(b)(5)(i) shall, when exposed to film in a two minute fog test, produce an increase in fog of not more than:
      1. 0.02 density units in film processing areas or devices used to develop mammography films,
      2. 0.05 density units in film processing areas or devices not used to develop mammography films.
    3. In determining compliance with F.3(b)(5)(ii), fog measurements are to be made at exposed film densities of 1.0 plus base plus fog.
3. Quality Assurance.
  The registrant shall be responsible for establishing and operating an effective program for radiographic imaging quality control. This program shall be designed to fulfill the following goals:
  1. That the diagnostic quality of radiographic images will be maintained at the highest level;
  2. That film processing systems will be maintained at the highest quality level;
  3. That radiographic images will be produced using the minimum radiation doses to patients; and
  4. That the above three goals will be consistently met.
  No person shall modify a radiation machine, or any other auxiliary equipment that functions with the radiation machine to produce the result desired by use of the machine, in such a manner that the machine or auxiliary equipment fails to operate properly or otherwise does not meet any provision of these regulations.

Sec. F.4 General Requirements for All Diagnostic X-Ray Systems.

In addition to other requirements of this part, all diagnostic x-ray systems shall meet the following requirements:

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 and operating instructions are observed."
Battery Charge Indicator.
On battery-powered x-ray 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.
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 100 milliroentgens (25.8 µC/kg) in 1 hour when the x-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
Radiation from Components Other Than the Diagnostic Source Assembly.
The radiation emitted by a component other than the diagnostic source assembly shall not exceed 2 milliroentgens (0.516 µC/kg) 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.
Beam Quality.
1. Half-Value Layer.
  1. The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table I. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table I, linear interpolation or extrapolation may be made.
  2. In addition to the requirements of F.4(e)(1)(i), all intraoral dental radiographic systems manufactured on and after December 1, 1980, shall have a minimum half-value layer not less than 1.5 millimeters aluminum equivalent filtration permanently installed in the useful beam.
  3. Beryllium window tubes shall have a minimum of 0.5 millimeter aluminum equivalent filtration permanently installed in the useful beam.
  4. For capacitor energy storage equipment, compliance with the requirements of F.4(e) shall be determined with the maximum quantity of charge per exposure.
  5. The required minimal aluminum equivalent filtration shall include the filtration contributed by all materials which are always present between the source and the patient.
2. Filtration Controls. For x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s) and shall prevent an exposure unless the minimum amount of filtration required by F.4(e)(1) is in the useful beam for the given kVp which has been selected.
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. Non-certified equipment is exempt from this requirement.
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.
Technique Indicators.
1. 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.
2. The requirement of F4(h) (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.

Table 2:
Half-Value Layers

Design Operating Range (kVp)	Measured Potential (kVp)	Half-value layer (mm of aluminum)
Below 50	30	0.3
Below 50	40	0.4
Below 50	49	0.5

50 to 70	50	1.2
50 to 70	60	1.3
50 to 70	70	1.5

Above 70	71	2.1
Above 70	80	2.3
Above 70	90	2.5
Above 70	100	2.7
Above 70	110	3.0
Above 70	120	3.2
Above 70	130	3.5
Above 70	140	3.8
Above 70	150	4.1

Sec. F.5 Fluoroscopic X-Ray Systems Except for Computed Tomography X-Ray Systems

All fluoroscopic x-ray systems shall meet the following requirements:

Limitation of Useful Beam.
1. Primary Barrier.
  1. 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.
  2. The x-ray tube used for fluoroscopy shall not produce x rays unless the barrier is in position to intercept the entire useful beam.
2. X-Ray Field.
  1. The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. This requirement applies to field size for both fluoroscopic procedures and spot filming procedures. In addition:
    1. means shall be provided for stepless adjustment of the field size;
    2. the minimum field size at the greatest SID shall be equal to or less than 5 centimeters by 5 centimeters;
    3. for 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; and
    4. compliance with F.5(a)(2)(i) shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
  2. For image-intensified fluoroscopic equipment, neither the length nor the 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. In addition:
    1. means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the x-ray field;
    2. all equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided with either stepless adjustment of the x-ray field or with means to further limit the x-ray field size at the plane of the image receptor to 125 square centimeters or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size of 5 centimeters by 5 centimeters or less;
    3. for equipment manufactured after February 25, 1978, when the angle between 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
    4. compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. For rectangular x-ray fields used with circular image reception, 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.
  3. Spot-film devices which are certified components shall meet the following additional requirements:
    1. means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the film to the size of that portion of the film which has been selected on the spot film selector. Such adjustment shall be automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot film devices manufactured after June 21, 1979, if the x-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option;
    2. it shall be possible to adjust the x-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, 5 centimeters by 5 centimeters;
    3. the center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within 2 percent of the SID; and
    4. 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.
    5. spot film exposure control devices shall meet the time and exposure requirements of F.6.
  4. If a means exists to override any of the automatic x-ray field size adjustments required in F5(a)(2), that means:
    1. shall be designed for use only in the event of system failure;
    2. shall incorporate a signal visible at the fluoroscopist's position which will indicate whenever the automatic field size adjustment is overridden; and
    3. shall be clearly and durably labeled as follows:

For X-Ray Field
Limitation System Failure

Sec. F.6 Radiographic Systems Other Than Fluoroscopic, Dental Intraoral, Veterinarian, or Computed Tomography X-Ray Systems

Beam Limitation. The useful beam shall be limited to the area of clinical interest.
1. General Purpose Stationary and Mobile X-Ray Systems.
  1. There shall be provided a means for stepless adjustment of the size of the x-ray field.
  2. A method shall be provided for visually defining the perimeter of the x-ray field. 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.
2. Additional Requirements for Stationary General Purpose X-Ray Systems. In addition to the requirements of F.6(a)(1), stationary general purpose x-ray systems, both certified and noncertified, shall meet the following requirements:
  1. A method 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;
  2. The beam-limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted; and
  3. Indication of field size dimensions and SID's shall be specified in inches and/or centimeters, 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.
3. 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 the 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 any edge of the image receptor.
4. Systems Designed for or Provided with Special Attachments for Mammography. Radiographic systems designed only for mammography and general purpose radiographic systems, when special attachments for mammography are in service, 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 which performs as prescribed in F.6(a)(5)(iii). 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 F.6(a)(5)(iii)(a) and (b) shall be the maximum SID for which the beam-limiting device or aperture is designed. In addition, each image receptor support intended for installation on a system designed only for mammography shall have clear and permanent markings to indicate the maximum image receptor size for which it is designed.
5. X-Ray Systems Other Than Those Described in F.6(a)(1),(2),(3), and (4).
  1. Means shall be provided 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. Podiatry units with a circular beam are exempted from the 2% limit provided the diameter of the x-ray field shall not exceed the diagonal dimension of the image receptor.
  2. 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 align 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.
  3. F.6(a)(5)(i) and (ii) may be met with a system that meets the requirements for a general purpose x-ray system as specified in F.6(a)(1) or, when alignment means are also provided, may be met with either:
    1. 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 with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
    2. 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. Source to Image Distance
  Except for certified systems, a method shall be provided to indicate the SID to within 2 inches.
Radiation Exposure Control Devices.
1. Timers.
  1. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. Such means shall provide that the resulting time interval product of current and time, number of pulses or radiation exposure is accurate to within ten percent of the true value.
  2. 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.
2. X-Ray Control.
  1. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time except for:
    1. exposure of one-half (l/2) second or less, or
    2. during serial radiography when means shall be provided to permit completion of any single exposure of the series in process.
  2. Each x-ray control shall be located in such a way as to meet the following requirements:
    1. 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; and
    2. mobile and portable x-ray systems which are:
      1. used for greater than 1 week in the same location, i.e., a room or suite, shall meet the requirements of F.6(b)(2)(ii)(a);
      2. used for greater than 1 hour and less than 1 week at the same location, i.e., a room or suite, shall meet the requirement of F.6(b)(2)(ii)(a) or the operator shall be protected by 6.5 feet (1.98 m) high or greater protective barrier which is placed so as to intercept both direct radiation from the tube housing and radiation scattered from the patient; or
      3. used to make an exposure(s) of a patient at the use location shall meet the requirement of F.6(b)(2)(ii)(a) or (b) or be provided with a method of x-ray control which will permit the operator to be at least 12 feet (3.66 m) from the tube housing assembly during an exposure; and
    3. Means shall be provided so that the operator can view the patient during the exposure.
    4. The x-ray control shall provide 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.
  3. Accuracy Except for certified systems, means shall be provided to terminate an exposure at a preset time interval, preset product of current and time, or preset number of pulses. Such means shall produce a time interval, product of current and time, or number of pulses within 10 percent of the indicated preset value.
3. Automatic Exposure Controls. When an automatic exposure control is provided:
  1. indication shall be made on the control panel when this mode of operation is selected;
  2. if the x-ray tube potential is equal to or greater than 50 kVp, the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to 2 pulses;
  3. the minimum exposure time for all equipment other than that specified in F.6(b)(3)(ii) shall be equal to or less than one-sixtieth (1/60) second or a time interval required to deliver 5 mAs, whichever is greater;
  4. either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than 60 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 that, when the x-ray tube potential is less than 50 kVp, the product of x-ray tube current and exposure time shall be limited to not more than 2000 mAs per exposure; and
  5. a visible signal shall indicate when an exposure has been terminated at the limits required by F.6(b)(3)(iv), and manual resetting shall be required before further automatically timed exposures can be made.
4. Reproducibility. With a timer setting of 0.5 seconds or less, the average exposure period (T) shall be greater than or equal to 5 times the maximum exposure period (T_max) minus the minimum exposure period (T_min) when 4 timer tests are performed: _
  T % 5 (T_max - T_min).
5. Linearity. When the equipment allows a choice of current settings, for any fixed x-ray tube potential within the range of 40-100 percent of the maximum rating, the average ratio of exposure to the indicated milliamp-second product obtained at any two consecutive tube current settings shall not differ by more than 0.20 times their sum:
  _ _ _ _
  %Y₁ - Y₂% % 0.20 (Y₁ + Y₂),
  _ _
  where Y₁ - Y₂ are the average mR/mAs (microcoulomb/kilogram per mAs) values obtained at each of 2 consecutive tube current settings.
Source-to-Skin Distance. All mobile or portable radiographic systems shall be provided with means to limit the source-to-skin distance to equal to or greater than 30 centimeters.
Exposure Reproducibility. The coefficient of variation of exposure shall not exceed 0.10 when all technique factors are held constant. This requirement shall be deemed to have been met if, when four exposures are made at identical technique factors, the value of the average exposure (E) is greater than or equal to 5 times the maximum exposure (E _max) minus the minimum exposure (E _min):
_
E % 5(E_max - E_min).
kVp Accuracy. Except for certified systems, the true value of kVp shall not be different from the indicated value by greater than ten percent.
Radiation from Capacitor Energy Storage Equipment in Standby Status. Radiation emitted from the x-ray tube when the exposure switch or timer is not activated shall not exceed a rate of 2 milliroentgens (0.516 µC/kg) per hour at 5 centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.
Additional Requirements Applicable to Certified Systems Only. Diagnostic x-ray systems incorporating one or more certified component(s) shall be required to comply with the following additional requirement(s) which relate to that certified component(s).
1. Reproducibility. When the equipment is operated on an adequate power supply as specified by the manufacturer in accordance with the requirements of applicable Federal standards, the estimated coefficient of variation of radiation exposures shall be no greater than 0.05, for any specific combination of selected technique factors.
2. Linearity. When the equipment allows a choice of x-ray tube current settings and is operated on a power supply as specified by the manufacturer in accordance with the requirements of applicable federal standards, for any fixed x -ray tube potential within the range of 40 to 100 percent of the maximum rating, the average ratios of exposure to the indicated milliampere-seconds product obtained at any 2 consecutive tube current settings shall not differ by more than 0.10 times their sum: _ _ _ _
  %X₁ - X₂% % 0.10 (X₁ + X₂),
  _ _
  where X ₁ and X ₂ are the average mR/mAs (microcoulomb/kilogram per mAs) values obtained at each of 2 consecutive tube current settings.
3. Accuracy. Deviation of technique factors from indicated values shall not exceed the limits specified for that system by its manufacturer.
4. Beam Limitation for Stationary and Mobile General Purpose X-Ray Systems.
  1. There shall be provided a means of stepless adjustment of the size of the x-ray field. The minimum field size at an SID of 100 centimeters shall be equal to or less than 5 centimeters by 5 centimeters.
  2. When a light localizer is used to define the x-ray field, it shall provide an average illumination of not less than 160 lux or 15 footcandles at 100 centimeters or at the maximum SID, whichever is less. The average illumination shall be based upon measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems manufactured on and after May 27, 1980, are exempt from this requirement.
  3. The edge of the light field at 100 centimeters 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 equipment. The contrast ratio is defined as I ₁/I ₂ where I₁ is the illumination 3 millimeters from the edge of the light field toward the center of the field; and I ₂ is the illumination 3 millimeters from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring instrument aperture of 1 millimeter in diameter.
  4. A method shall be provided to indicate the SID to within 2 percent of its true value when the axis of the x-ray beam is perpendicular to the plane of he image receptor.
5. Beam Limitation for Portable X-Ray Systems. Beam limitation for portable x-ray systems shall meet the beam limitation requirements of F.6(a)(1) and F.6(g)(4).
6. Timers. Except for dental panoramic systems, termination of exposure shall cause automatic resetting of the timer to its initial setting or to "zero."
7. Transmission Limit for Image Receptor Supporting Devices Used for Mammography. For x-ray systems manufactured after September 5, 1978 which are designed only for mammography, the transmission of the primary beam through any image receptor support provided withthe system shall be limited such that the exposure 5 centimeters from any accessible surface beyond the plane of the image receptor supporting device does not exceed 0.1 milliroentgen (25.8 nC/kg) for each activation of the tube. Exposure shall be measured with the system operated at the minimum SID for which it is designed. Compliance shall be determined at the maximum rated peak tube potential for the system and at the maximum rated product of tube current and exposure time (mAs) for that peak tube potential. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

Sec. F.7 Intraoral Dental

Radiographic Systems. In addition to the provisions of F.3 and F.4, the requirements of F.7 apply to x-ray equipment and associated facilities used for dental radiography. Requirements for extraoral dental radiographic systems are covered in F.6.

Source-to-Skin Distance. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit source-to- skin distance, to not less than:
1. 18 centimeters if operable above 50 kVp, or
2. 10 centimeters if not operable above 50 kVp.
Field Limitation.
1. Radiographic systems designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:
  1. if the minimum source-to-skin-distance (SSD) is 18 centimeters or more, the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than 7 centimeters; and
  2. if the minimum SSD is less than 18 centimeters,the x-ray field, at the minimum SSD, shall be containable in a circle having a diameter of no more than 6 centimeters.
2. An open ended, shielded position indicating device shall be used.
Timers. Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor. In addition:
1. 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.
2. Reproducibility. With a timer setting of 0.5 seconds or less, the average exposure period (T) shall be greater than or equal to 5 times the maximum exposure period (T _max) minus the minimum exposure period (T _min) when 4 timer tests are performed:
              _
                      T % 5(T_max - T_min).
3. Accuracy. Except for certified systems, means shall be provided to terminate exposure at a preset time interval, preset product of current and time, or preset number of pulses. Such means shall produce a time interval, product of current and time, or number of pulses within ten percent of the indicated preset value.
X-Ray Control.
1. An x-ray control shall be incorporated into each x-ray system such that an exposure can be terminated by the operator at any time, except for exposures of one-half (1/2) second or less.
2. Each x-ray control shall be located in such a way as to meet the following requirements:
  1. 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; and
  2. mobile and portable x-ray systems which are:
    1. used for greater than 1 week in the same location, i.e., a room or suite, shall meet the requirements of F.7(d)(2)(i);
    2. used for greater than 1 hour and less than 1 week at the same location, i.e., a room or suite, shall meet the requirements of F.7(d)(2)(ii)(a) or be provided with a 6.5 feet (1.98 m) high protective barrier which is placed at least 6 feet (1.83 m) from the tube housing assembly and at least 6 feet (1.83 m) from the patient; or
    3. used to make an exposure(s) of a patient at the use location shall meet the requirement of F.7(d)(2)(ii)(a) or (b) or be provided with a method of x-ray control which will permit the operator to be at least 12 feet (3.66 m) from the tube housing assembly during an exposure.
3. The x-ray control shall provide 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.
Exposure Reproducibility. The coefficient of variation shall not exceed 0.10 when all technique factors are held constant. This requirement shall be deemed to have been met if, when 4 exposures are made at identical technique factors, the value of the average exposure (E) is greater than or equal to 5 times the maximum exposure (E _max) minus the minimum exposure (E _min):
E % 5(E_max - E_min).
kVp Accuracy. Except for certified systems, the true value of kVp shall not be different from the indicated value by greater than ten percent.
Administrative Controls.
1. Patient and film holding devices shall be used when the techniques permit.
2. The tube housing and the PID shall not be hand-held during an exposure.
3. The x-ray system shall be operated in such a manner that the useful beam at the patient's skin does not exceed the requirements of F.7(b)(1).
4. Dental fluoroscopy without image intensification shall not be used.
Additional Requirements Applicable to Certified Systems Only.
Only diagnostic x-ray systems incorporating one or more certified component(s) shall be required to comply with the following additional requirement(s) which relate to that certified component(s).
1. Reproducibility. When the equipment is operated on an adequate power supply as specified by the manufacturer, the estimated coefficient of variation of radiation exposures shall be no greater than 0.05, for any specific combination of selected technique factors.
2. Linearity. When the equipment allows a choice of x-ray tube current settings and is operated on a power supply as specified by the manufacturer in accordance with the requirements of applicable federal standards, for any fixed x-ray tube potential within the range of 40 to 100 percent of the maximum rating, the average ratios of exposure to the indicated milliampere-seconds product obtained at any 2 consecutive tube current settings shall not differ by more than 0.10 times their sum: _ _ _ _
  %X₁ - X₂% % 0.10 (X₁ + X₂),
  _ _
  where X ₁ and X ₂ are the average mR/mAs values obtained at each of 2 consecutive tube current settings.
3. Accuracy. Deviation of technique factors from indicated values shall not exceed the limits specified for that system by its manufacturer.
4. Timers. Termination of exposure shall cause automatic resetting of the timer to its initial setting or to "zero".
5. Beam Quality. All certified dental x-ray systems manufactured on and after December 1, 1980, shall have a minimum half-value layer not less than 1.5 millimeters aluminum equivalent. Systems operating above 70 kVp are subject to the filtration requirements of F.4(e)(1).

Sec. F.8 Therapeutic X-Ray Systems of Less Than One MeV

Equipment Requirements.
1. Leakage Radiation. When the tube is operated at its leakage technique factors, the leakage radiation shall not exceed the value specified at the distance specified for the classification of that x-ray system.
  1. Contact Therapy Systems. Leakage radiation shall not exceed 100 milliroentgens (25.8 µC/kg) per hour at 5 centimeters from the surface of the tube housing assembly.
  2. 0-150 kVp Systems. Systems which were manufactured or installed prior to December 6, l982 shall have a leakage radiation which does not exceed 1 roentgen (0.258 mC/kg) in 1 hour at 1 meter from the source.
  3. 0-150 kVp Systems. Systems which are manufactured on or after December 6, l982 shall have a leakage radiation which does not exceed 100 milliroentgens (25.8 µC/kg) in 1 hour at 1 meter from the source.
  4. 151 to 999 kVp Systems. The leakage radiation shall not exceed 1 roentgen (0.258 mC/kg) in 1 hour at 1 meter from the source except systems that operate in excess of 500 kVp may have a leakage radiation at 1 meter from the source not to exceed 0.1 percent of the useful beam 1 meter from the source.
2. Permanent Beam Limiting Devices. Permanent fixed diaphragms or cones used for limiting the useful beam shall provide the same or a higher degree of protection as required for the tube housing assembly.
3. Removable and Adjustable Beam Limiting Devices.
  1. Removable beam limiting devices shall, for the portion of the useful beam to be blocked by these devices, transmit not more than 1 percent of the useful beam at the maximum kilovoltage and maximum treatment filter. This requirement does not apply to auxiliary blocks or materials placed in the useful beam to shape the useful beam to the individual patient.
  2. Adjustable beam limiting devices installed after December 6, l982 shall meet the requirements of F.8(a)(3)(i).
  3. Adjustable beam limiting devices installed before December 6, l982 shall, for the portion of the x-ray beam to be blocked by these devices, transmit not more than 5 percent of the useful beam at the maximum kilovoltage and maximum treatment filter.
4. Filter System. The filter system shall be so designed that:
  1. the filters cannot be accidentally displaced at any possible tube orientation;
  2. the radiation at 5 centimeters from the filter insertion slot opening does not exceed 30 roentgens (7.74 mC/kg) per hour under any operating conditions; and
  3. each filter is marked as to its material of construction and its thickness. For wedge filters, the wedge angle shall appear on the wedge or wedge tray.
5. Tube Immobilization. The tube housing assembly shall be capable of being immobilized for stationary treatments.
6. Focal Spot Marking. The tube housing assembly shall be so marked that it is possible to determine the location of the focal spot to within 5 millimeters, and such marking shall be readily accessible for use during calibration procedures.
7. Beam Block. Contact therapy tube housing assemblies shall have a removable shield of at least 0.5 millimeter lead equivalency at 100 kVp that can be positioned over the entire useful beam exit port during periods when the beam is not in use.
8. Beam Monitor System. Systems of greater than 150 kVp manufactured after December 6, l982 shall be provided with a beam monitor system which:
  1. shall have the detector of the monitor system interlocked to prevent incorrect positioning;
  2. shall not allow irradiation until a pre-selected value of exposure has been made at the treatment control panel;
  3. shall independently terminate irradiation when the preselected exposure has been reached;
  4. shall be so designed that, in the event of a system malfunction or electrical power failure, the dose administered to a patient prior to the system malfunction or power failure can be accurately determined;
  5. shall have a display at the control panel from which the dose at a reference point in soft tissue can be calculated;
  6. shall have a control panel display which maintains the administered dose reading until intentionally reset to zero; and
  7. shall have a control panel display which does not have scale multiplying factors and utilizes a design such that increasing dose is displayed by increasing numbers.
9. Timer.
  1. A timer which has a display shall be provided at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time indicator.
  2. The timer shall be a cumulative timer which activates with the production of radiation and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator to zero.
  3. The timer shall terminate irradiation when a preselected time has elapsed if any dose monitoring system present has not previously terminated irradiation.
  4. The timer shall permit accurate presetting and determination of exposure times as short as 1 second.
  5. The timer shall not permit an exposure if set at zero.
  6. The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism.
10. Control Panel Functions. The control panel, in addition to the displays required in other provisions of F.8, shall have:
  1. an indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;
  2. an indication of whether x rays are being produced;
  3. means for indicating x-ray tube potential and current;
  4. means for terminating an exposure at any time;
  5. a locking device which will prevent unauthorized use of the x-ray system; and
  6. for x-ray systems manufactured after December 6, l982, a positive display of specific filter(s) in the beam.
11. Multiple Tubes. When a control panel may energize more than one x-ray tube:
  1. It shall be possible to activate only one x-ray tube at any time.
  2. There shall be an indication at the control panel identifying which x-ray tube is energized.
  3. There shall be an indication at the tube housing assembly when that tube is energized.
12. Source-to-Skin Distance. There shall be means of determining the SSD to within 1 centimeter.
13. Shutters. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within 5 seconds, the beam shall be automatically attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition,
  1. after the unit is at operating parameters, the shutter shall be controlled electrically by the operator from the control panel; and
  2. an indication of shutter position shall appear at the control panel.
14. Low-Filtration X-Ray Tubes. Each x-ray system equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and at the control panel.
Facility Design Requirements for X-Ray Systems Capable of Operating Above 50 kVp.
1. Aural Communication. Provision shall be made for two-way aural communication between the patient and the operator at the control panel. However, where excessive noise levels or treatment requirements make aural communication impractical, other methods of communication shall be used.
2. Viewing Systems.
  1. Windows, mirrors, closed-circuit television, or an equivalent system 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.
  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.
3. Additional Requirements for X-Ray Systems Capable of Operation Above 150 kVp.
  1. All protective barriers shall be fixed except for entrance doors or beam interceptors.
  2. The control panel shall be located outside the treatment room.
  3. Entrance Interlocks. Interlocks shall be provided such that all entrance doors must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.
  4. When any door referred to in F.8(b)(3)(iii) is opened while the x-ray tube is activated, the exposure at a distance of 1 meter from the source shall be reduced to less than 100 milliroentgens (25.8 µC/kg) per hour.
Surveys, Calibrations, Spot Checks, and Operating Procedures.
1. Surveys.
  1. All new facilities, and existing facilities not previously surveyed, shall have a survey made by, or under the direction of, a qualified expert. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.
  2. The registrant shall obtain a written report of the survey from the qualified expert, and a copy of the report shall be transmitted by the registrant to the Agency within 30 days of receipt of the report.
  3. The survey and report shall indicate all instances where the installation, in the opinion of the qualified expert, is in violation of applicable regulations.
2. Calibrations.
  1. The calibration of an x-ray system shall be performed at intervals not to exceed 1 year and after any change or replacement of components which could cause a change in the radiation output.
  2. The calibration of the radiation output of the x-ray system shall be performed by or under the direction of a qualified expert who is physically present at the facility during such calibration.
  3. Calibration of the radiation output of an x-ray system shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard. The system shall have been calibrated within the preceding 2 years.
  4. The calibrations shall be such that the dose at a reference point in soft tissue can be calculated to within an uncertainty of 5 percent.
  5. The calibration of the x-ray system shall include, but not be limited to, the following determinations:
    1. verification that the x-ray system is operating in compliance with the design specifications;
    2. the exposure rates as a function of field size, technique factors, filter, and treatment distance used;
    3. the degree of congruence between the radiation field and the field indicated by the localizing device if such device is present; and
    4. an evaluation of the uniformity of the largest radiation field used.
  6. Records of calibration shall be maintained by the registrant for 5 years after completion of the calibration.
  7. A copy of the most recent x-ray system calibration shall be available at or in the area of the control panel.
3. Spot Checks. Spot checks shall be performed on x-ray systems capable of operation at greater than 150 kVp. Such spot checks shall meet the following requirements:
  1. The spot-check procedures shall be in writing and shall have been developed by a qualified expert. A copy of the procedures shall be submitted to the Agency prior to their implementation.
  2. If a qualified expert does not perform the spot-check measurement, the results of the spot-check measurements shall be reviewed by a qualified expert within 15 days.
  3. The spot-check procedures shall specify the frequency at which tests or measurements are to be performed. The spot-check procedures shall specify that the spot check shall be performed during the calibration specified in F.8(c)(2). The acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the calibration specified in F.8(c)(2) shall be stated.
  4. The cause for a parameter exceeding a tolerance set by the qualified expert shall be investigated and corrected before the system is used for patient irradiation.
  5. Whenever a spot check indicates a significant change in the operating characteristics of a system, as specified in the qualified expert's spot-check procedures, the system shall be recalibrated as required in F.8(c)(2).
  6. Records of spot-check measurements shall be maintained by the registrant for 2 years after completion of the spot-check measurements and any necessary corrective actions.
  7. Where a spot check involves a radiation measurement, such measurement shall be obtained using a system satisfying the requirements of F.8(c)(2) or which has been intercompared with a system meeting those requirements within the previous year.
4. Operating Procedures.
  1. X-ray systems shall not be left unattended unless the system is secured against unauthorized use.
  2. When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used.
  3. The tube housing assembly shall not be held by hand during operation unless the system is designed to require such holding and the peak tube potential of the system does not exceed 50 kVp. In such cases, the holder shall wear protective gloves and apron of not less than 0.5 mm lead equivalency at 100 kVp.
  4. No individual other than the patient shall be in the treatment room unless such individual is protected by a barrier sufficient to meet the requirements of D.201 of these regulations. No individual other than the patient shall be in the treatment room during exposures from x-ray systems operating above 150 kVp.
  5. The x-ray system shall not be used in the administration of radiation therapy unless the requirements of F.8(c)(2) and F.8(c)(3)(v) have been met.
Sec. F.10 Veterinary Medicine Radiographic Installations
1. Equipment.
  1. The protective tube housing shall meet the requirements of F.4(c).
  2. Diaphragms or cones shall be provided for collimating the useful beam to the area of clinical interest and shall meet the requirements of Sections F.6(a)(1)(ii), or F.6(a)(5), and F.6(a)(6), and shall provide the same degree of protection as is required of the protective tube housing.
  3. The total filtration permanently in the useful beam shall not be less than 0.5 millimeters aluminum equivalent for machines operating up to 50 kVp, 1.5 millimeters aluminum equivalent for machines operating between 50 and 70 kVp, and 2.5 millimeters aluminum equivalent for machines operating above 70 kVp.
  4. A device shall be provided to terminate the exposure after a preset time or exposure.
  5. A dead-man type of exposure switch shall be provided, together with an electrical cord of sufficient length, so that the operator can stand out of the useful beam and at least 6 feet (1.83 m) from the animal during all x-ray exposures.
2. Structural Shielding.
  All wall, ceiling, and floor areas shall be equivalent to or provided with applicable protective barriers to assure compliance with D.201, D.207, and D.301 of these regulations.
3. Operating Procedures.
  1. The operator shall stand well away from the useful beam and the animal during radiographic exposures.
  2. No individual other than the operator shall be in the x-ray room while exposures are being made unless such individual's assistance is required.
  3. When an animal must be held in position during radiography, mechanical supporting or restraining devices should be used. If the animal must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective gloves and apron, and he shall be so positioned that no part of his body will be struck by the useful beam. The exposure of any individual used for this purpose shall be monitored.
Sec. F.11 Computed Tomography X-Ray Systems
1. Definitions.
  In addition to the definitions provided in A.2 and F.2 of these regulations, the following definitions shall be applicable to F.11:
  Computed tomography dose index means the integral from -7T to +7T 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:
  1 %+7T
  CTDI = %_-7T D(z)dz
  nT
  
  where:
  
  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:
  µ_x - µ_w CS =
  (CTN)_x - (CTN)_w
  
  where:
  µ_x = Linear attenuation coefficient of the material of interest.
  µ_w = Linear attenuation coefficient of water.
  (CTN)_x = CTN of the material of interest.
  (CTN)_w = CTN of water.
  CS (See Contrast scale).
  CT conditions of operation" means all selectable parameters governing the operation of a CT x-ray system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in F.2.
  CTDI (See Computed tomography dose index).
  CT gantry means the tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames which hold these components.
  CTN (See CT number).
  CT number means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.
  k( µ_x - µ_w)
  CTN =
  µ_w
  where:
  k = A constant [5/]
  µ_x = Linear attenuation coefficient of the material of interest.
  µ_w = Linear attenuation coefficient of water.
  Dose profile means the dose as a function of position along a line.
  Elemental area means the smallest area within a tomogram for which the x-ray attenuation properties of a body are depicted. (See also Picture element).
  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 (S_n) is calculated using the following expression:
  
       S_n = 100 x CS x s
       µ_w
  
  5/ The constant has a normal value of 1,000 when the Houndsfield scale of CTN is used.
  where: CS = Contrast scale
  µ_w = Linear attenuation coefficient of water.
  s = Estimated standard deviation of the CTN of picture elements in a specified area of the CT image.
  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.
  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 preselected set of two or more scans performed consecutively under preselected CT conditions of operation.
  Scan time means the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.
  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 is 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.
2. Requirements for Equipment.
  1. Termination of Exposure.
    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.
    2. A visible signal shall indicate when the x-ray exposure has been terminated through the means required by F.11(b)(1)(i).
    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.
  2. Tomographic Plane Indication and Alignment.
    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.
    2. For any multiple tomogram system, means shall be provided to permit visual determination of the location of reference plane. This reference plane can be offset from the location of the tomographic planes.
    3. If a device using a light source is used to satisfy F.11(b)(2)(i) or (ii), 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.
  3. Beam-On and Shutter Status Indicators and Control Switches.
    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.
    2. Each emergency button or switch shall be clearly labeled as to its function.
  4. 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.
  5. Extraneous Radiation.
    When data are not being collected for image production, the radiation adjacent to the tube port shall not exceed that permitted by F.4(c).
  6. 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.
  7. Additional Requirements Applicable to CT X-Ray Systems Containing a Gantry Manufactured After September 3, 1985.
    1. The total error in the indicated location of the tomographic plane or reference plane shall not exceed 5 millimeters.
    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.
    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.
    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.
3. Facility Design Requirements.
  1. Aural Communication.
    Provision shall be made for two-way aural communication between the patient and the operator at the control panel.
  2. Viewing Systems.
    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.
    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.
4. Surveys, Calibrations, Spot Checks, and Operating Procedures.
  1. Surveys.
    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 expert. In addition, such surveys shall be done after any change in the facility or equipment which might cause a significant increase in radiation hazard.
    2. The registrant shall obtain a written report of the survey from the qualified expert, and a copy of the report shall be made available to the Agency upon request.
  2. Radiation Calibrations.
    1. The calibration of the radiation output of the CT x-ray system shall be performed by, or under the direction of, a qualified expert who is physically present at the facility during such calibration.
    2. The calibration of a CT x-ray system shall be performed at intervals specified by a qualified expert and after any change or replacement of components which, in the opinion of the qualified expert, could cause a change in the radiation output.
    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.
    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:
      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.
      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.
      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.
      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.
    5. The calibration shall be required for each type of head, body, or whole-body scan performed at the facility.
    6. Calibration shall meet the following:
      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 three nominal tomographic thicknesses can be selected, the dose profile determination shall be performed for each available nominal tomographic section thickness.
      2. The CTDI [6/] along the two axes specified in F.11(d)(2(iv)(b) 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.
      3. The spot checks specified in F.11(d)(3) shall be made.
    7. Calibration procedures shall be in writing. Records of calibrations performed shall be maintained for inspection by the Agency.
  3. Spot Checks.
    1. The spot-check procedures shall be in writing and shall have been developed by a qualified expert.
    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.
      6/ For the purpose of determining the CTDI, the manufacturer's statement as to the nominal tomographic section thickness for that particular system may be utilized.
    3. All spot checks shall be included in the calibration required by F.11(d)(2) and at time intervals and under system conditions specified by a qualified expert.
    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 F.11(d)(2). The images shall be retained, until a new calibration is performed, in two forms as follows:
      1. photographic copies of the images obtained from the image display device; and
      2. images stored in digital form on a storage medium compatible with the CT x-ray system.
    5. Written records of the spot checks performed shall be maintained for inspection by the Agency.
  4. Operating Procedures.
    1. The CT x-ray system shall not be operated except by an individual who has been specifically trained in its operation.
    2. Information shall be available at the control panel regarding the operation and calibration of the system. Such information shall include the following:
      1. dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained;
      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;
      3. the distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and
      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.
    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 expert, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the qualified expert.
Part H
Radiation Safety Requirements for Analytical X-Ray Equipment

Sec. H.1 Purpose and Scope
This part provides special requirements for analytical x-ray equipment. The requirements of this part are in addition to, and not in substitution for, applicable requirements in other parts of these regulations.

Sec. H.2 Definitions
As used in this part, the following definitions apply:
Analytical x-ray equipment means equipment used for x-ray diffraction or fluorescence analysis.
Analytical x-ray system means a group of components utilizing x or gamma rays to determine the elemental composition or to examine the microstructure of materials.
Fail-safe characteristics mean a design feature which causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.
Local components mean part of an analytical x-ray system and include areas that are struck by x rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.
Normal operating procedures mean step-by-step instructions necessary to accomplish the analysis. These procedures shall include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant [or licensee], and data recording procedures, which are related to radiation safety.
Open-beam configuration means an analytical x-ray system in which an individual could accidentally place some part of his body in the primary beam path during normal operation.
Primary beam means radiation which passes through an aperture of the source housing by a direct path from the x-ray tube or a radioactive source located in the radiation source housing.

Sec. H.3 Equipment Requirements

Safety Device
A device which prevents the entry of any portion of an individual's body into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A registrant or licensee may apply to the Agency for an exemption from the requirement of a safety device. Such application shall include:
1. a description of the various safety devices that have been evaluated;
2. the reason each of these devices cannot be used; and
3. a description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.
Warning Devices
1. Open-beam configurations shall be provided with a readily discernible indication of:
  1. x-ray tube "on-off" status located near the radiation source housing, if the primary beam is controlled in this manner; and/or
  2. shutter "open-closed" status located near each port on the radiation source housing, if the primary beam is controlled in this manner.
2. An easily visible warning light labeled with the words "X-Ray on", or words having a similar intent, shall be located:
  1. near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized; or
  2. in the case of a radioactive source, near any switch that opens a housing shutter and shall be illuminated only when the shutter is open.
3. Warning devices shall be labeled so that their purpose is easily identified. On equipment installed after October 10, 1982 warning devices shall have fail-safe characteristics.
Ports
Unused ports on radiation source housings shall be secured in the closed position in a manner which will prevent casual opening.
Labeling
All analytical x-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:
1. "Caution - High Intensity X-Ray Beam", or words having a similar intent, on the x-ray source housing; and
2. "Caution Radiation - This Equipment Produces Radiation when Energized", or words having a similar intent, near any switch that energizes an x-ray tube if the radiation source is an x-ray tube; or
3. "Caution - Radioactive Material", or words having a similar intent, on the source housing in accordance with Part D of these regulations if the radiation source is a radionuclide.
Shutters
On open-beam configurations installed after October 10, 1982 each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
Radiation Source Housing.
Each radiation source housing shall be subject to the following requirements:
1. Each x-ray tube housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled.
2. Each radioactive source housing or port cover or each x-ray tube housing shall be so constructed that, with all shutters closed, the radiation measured at a distance of 5 centimeters from its surface is not capable of producing a dose in excess of 2.5 millirems (0.025 mSv) in one hour. For systems utilizing x-ray tubes, this limit shall be met at any specified tube rating.
Generator Cabinet
Each x-ray generator shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of 5 centimeters from its surface such that it is not capable of producing a dose in excess of 0.25 millirem (2.5 µSv) in one hour.

Sec. H.4 Area Requirements

Radiation Levels
The local components of an analytical x-ray system shall be located and arranged and shall include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits given in Part D of these regulations. For systems utilizing x-ray tubes, these levels shall be met at any specified tube rating
Surveys
1. Radiation surveys, as required by Part D of these regulations, of all analytical x-ray systems sufficient to show compliance with H.4(a) shall be performed:
  1. upon installation of the equipment, and at least once every 12 months thereafter;
  2. following any change in the initial arrangement, number, or type of local components in the system;
  3. following any maintenance requiring the disassembly or removal of a local component in the system;
  4. during the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled or removed;
  5. any time a visual inspection of the local components in the system reveals an abnormal condition; and
  6. whenever personnel monitoring devices show a significant increase over the previous monitoring period or the readings are approaching the limits specified in Part D of these regulations.
2. Radiation survey measurements shall not be required if a registrant or licensee can demonstrate compliance with H.4(a) to the satisfaction of the Agency.
Posting
Each area or room containing analytical x-ray equipment shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words "Caution - X-Ray Equipment" or words having a similar intent in accordance with Part D of these regulations.

Sec. H.5 Operating Requirements

Procedures
Normal operating procedures shall be written and available to all analytical x-ray equipment workers. No individual shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such individual has obtained written approval of the radiation safety officer.
Bypassing
No individual shall bypass a safety device or interlock unless such individual has obtained the approval of the radiation safety officer. Such approval shall be for a specified period of time. When a safety device or interlock has been bypassed, a readily discernible sign bearing the words "Safety Device Not Working", or words having a similar intent, shall be placed on the radiation source housing.
Repair or Modification of X-Ray Tube Systems
Except as specified in H.5(b), no operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.
Radioactive Source Replacement, Testing, or Repair
Radioactive source housings shall be opened for source replacement, leak testing, or other maintenance or repair procedures only by individuals authorized to specifically conduct such procedures under a license issued by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

Sec. H.6 Personnel Requirements

Instruction
No individual shall be permitted to operate or maintain analytical x-ray equipment unless such individual has received instruction in and demonstrated competence as to:
1. identification of radiation hazards associated with the use of the equipment;
2. significance of the various radiation warning, safety devices, and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;
3. proper operating procedures for the equipment;
4. recognition of symptoms of an acute localized exposure; and
5. proper procedures for reporting an actual or suspected exposure.
Personnel Monitoring
1. Finger or wrist dosimetric devices shall be provided to and shall be used by:
  1. analytical x-ray equipment workers using systems having an open-beam configuration and not equipped with a safety device; and
  2. personnel maintaining analytical x-ray equipment if the maintenance procedures require the presence of a primary x-ray beam when any local component in the analytical x-ray system is disassembled or removed.
2. Reported dose values shall not be used for the purpose of determining compliance with D.201 of these regulations unless evaluated by a qualified expert.

Part I
Radiation Safety Requirements for Particle Accelerators

Sec. I.1 Purpose and Scope

This part establishes procedures for the registration and the use of particle accelerators.
In addition to the requirements of this part, all registrants are subject to the requirements of Parts A, B, D, and J of these regulations. Registrants engaged in industrial radiographic operations are subject to the requirements of Part E of these regulations, and registrants engaged in the healing arts are subject to the requirements of Parts F and G of these regulations. Registrants whose operations result in the production of radioactive material are subject to the requirements of Part C of these regulations.

Sec. I.2 Registration Requirements

No person shall receive, possess, use, transfer, own, or acquire a particle accelerator except as authorized in a registration issued pursuant to Part B of these regulations.

Sec. I.3 General Requirements for the Issuance of a Registration for Particle Accelerators

In addition to the requirements of Part B of these regulations, a registration application for use of a particle accelerator will be approved only if the Agency determines that:

the applicant is qualified by reason of training and experience to use the accelerator for the purpose requested in accordance with this part and Parts D and J of these regulations in such a manner as to minimize danger to public health and safety or property;
the applicant's proposed or existing equipment, facilities, and operating and emergency procedures are adequate to protect health and minimize danger to public health and safety or property;
the issuance of the registration will not be inimical to the health and safety of the public, and the applicant satisfies any applicable special requirement in I.4;
the applicant has appointed a properly qualified radiation safety officer;
the applicant and the applicant's staff has substantial experience in the use of particle accelerators and training sufficient for application to its intended uses;
the applicant has established a radiation safety committee, whenever deemed necessary by the Agency, to approve in advance, proposals for uses of particle accelerators; and
the applicant has an adequate training program for operators of particle accelerators.

Sec. I.4 Human Use of Particle Accelerators

In addition to the requirements of Part B of these regulations, a registration for use of a particle accelerator in the healing arts will be issued only if:

the applicant has appointed a medical committee, whenever deemed necessary by the Agency, of at least three members to evaluate all proposals for research, diagnostic, and therapeutic use of a particle accelerator . Membership of the committee should include physicians expert in internal medicine, hematology, therapeutic radiology, and a person experienced in depth dose calculations and protection against radiation;
the individuals designated on the application as the users have substantial training and experience in deep therapy techniques or in the use of particle accelerators to treat humans; and
the individual designated on the application as the user is a physician.

Sec. I.5 Reserved

Sec. I.6 Limitations

No registrant shall permit any individual to act as an operator of a particle accelerator until such individual:
1. has been instructed in radiation safety and shall have demonstrated an understanding thereof;
2. has received copies of and instruction in this part and the applicable requirements of Parts D and J of these regulations, pertinent registration conditions and the registrant's operating and emergency procedures, and shall have demonstrated understanding thereof; and
3. has demonstrated competence to use the particle accelerator, related equipment, and survey instruments which will be employed.
The radiation safety committee and the radiation safety officer shall have the authority to terminate the operations at a particle accelerator facility if such action is deemed necessary to minimize danger to public health and safety or property.

Sec. I.7 Shielding and Safety Design Requirements

A qualified expert, acceptable to the Agency, shall be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation.
Each particle accelerator installation shall be provided with such primary and secondary barriers as are necessary to assure compliance with Part D of these regulations.

Sec. I.8 Particle Accelerator Controls and Interlock Systems

Instrumentation, readouts, and controls on the particle accelerator control console shall be functioning properly at all times, clearly identified, and easily discernible.
Each entrance into a target room or other high radiation area shall be provided with a safety interlock that shuts down the machine under conditions of barrier penetration.
Each safety interlock shall be on a circuit which shall allow it to operate independently of all other safety interlocks.
All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents operation of the accelerator.
When a safety interlock system has been tripped, it shall only be possible to resume operation of the accelerator by manually resetting controls at the position where the safety interlock has been tripped and, lastly, at the main control console.
A scram button or other emergency power cutoff switch shall be located and easily identifiable in all high radiation areas. Such a cutoff switch shall include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.

Sec. I.9 Warning Devices

Each location designated as a very high radiation area, and each entrance to such location, shall be equipped with easily observable warning lights as specified in D.602.b.i.(4).
Except in facilities designed for human exposure, each very high radiation area shall have an audible warning device which shall be activated for 15 seconds prior to the possible creation of such very high radiation area. Such warning device shall be clearly discernible in all very high radiation areas.
Barriers, temporary or otherwise, and pathways leading to very high radiation areas shall be posted in accordance with D.901 of these regulations.

Sec. I.10 Operating Procedures

Particle accelerators, when not in operation, shall be secured to prevent unauthorized use.
The safety interlock system shall not be used to turn off the accelerator beam except in an emergency.
All safety and warning devices, including interlocks, shall be checked for proper operation at intervals not to exceed 3 months. Results of such tests shall be maintained at the accelerator facility for inspection by the Agency.
Electrical circuit diagrams of the accelerator and the associated safety interlock systems shall be kept current and maintained for inspection by the Agency and shall be available to the operator at each accelerator facility.
If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action shall be:
1. authorized by the radiation safety committee or radiation safety officer;
2. recorded in a permanent log and a notice posted at the accelerator control console; and
3. terminated as soon as possible.
A copy of the current operating and the emergency procedures shall be maintained at the accelerator control panel.

Sec. I.11 Radiation Monitoring Requirements

Each location designated as a very high radiation area shall be surveyed immediately following each accelerator shutdown to determine that no radiation is emanating from the accelerator, before persons other than the surveyor are allowed to enter.
There shall be available at each particle accelerator facility appropriate portable monitoring equipment which is operable and has been appropriately calibrated for radiations being produced at the facility. Such equipment shall be tested for proper operation before each use and calibrated at intervals not to exceed 1 year and after each servicing and repair.
A radiation protection survey shall be performed and documented by a qualified expert, acceptable to the Agency, when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.
Radiation levels in all high radiation areas shall be continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel.
All area monitors shall be calibrated at intervals not to exceed 1 year and after each servicing and repair.
Whenever applicable, surveys shall be made to determine the amount of airborne particulate radioactivity present.
Whenever applicable, smear surveys shall be made to determine the degree of contamination.
All surveys shall be made in accordance with the written procedures established by a qualified expert, acceptable to the Agency, or the radiation safety officer.
Records of all radiation protection surveys, calibrations, and instrumentation tests shall be maintained at the accelerator facility for inspection by the Agency.

Sec. I.12 Ventilation Systems

Ventilation systems shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of those limits specified in Part D, Appendix B, Table I of these regulations.
A registrant shall not vent, release, or otherwise discharge airborne radioactive material to an unrestricted area which exceeds the limits specified in Part D, Appendix B, Table II of these regulations. For purposes of I.12(b), concentrations may be averaged over a period not greater than 1 year. Every effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as is reasonably achievable.

Part J
Notices, Instructions, and Reports to Workers; Inspections

Sec. J.1 Purpose and Scope.

This part establishes requirements for notices, instructions and reports by licensees or registrants to individuals engaged in activities under a license or registration and options available to such individuals in connection with Agency inspections of licensees or registrants to ascertain compliance with the provisions of the Act and regulations, orders, and licenses issued thereunder regarding radiological working conditions. The regulations in this part apply to all persons who receive, possess, use, own, or transfer sources of radiation registered with or licensed by the Agency pursuant to Parts B and C of these regulations.

Sec. J.11 Posting of Notices to Workers.

Each licensee or registrant shall post current copies of the following documents:
1. the regulations in this part and in Part D of these regulations;
2. the license, certificate of registration, conditions or documents incorporated into the license by reference and amendments thereto;
3. the operating procedures applicable to activities under the license or registration; and
4. any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued pursuant to Part A of these regulations, and any response from the licensee or registrant.
If posting of a document specified in J.11(a)(1), (2), or (3) is not practicable, the licensee or registrant may post a notice which describes the document and states where it may be examined.
Agency MDE 491 "Notice to Employees" shall be posted by each licensee or registrant as required by these regulations.
Agency documents posted pursuant to J.11(a)(4) shall be posted within 5 working days after receipt of the documents from the Agency; the licensee's or registrant's response, if any, shall be posted within 5 working days after dispatch from the licensee or registrant. Such documents shall remain posted for a minimum of 5 working days or until action correcting the violation has been completed, whichever is later.
Documents, notices, or forms posted pursuant to J.11 shall appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

Sec. J.12 Instructions to Workers.

All individuals working in or frequenting any portion of a restricted area:
1. shall be kept informed of the storage, transfer, or use of sources of radiation in such portions of the restricted area;
2. shall be instructed in the health protection problems associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;
3. shall be instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of these regulations and licenses for the protection of personnel from exposures to radiation or radioactive material occurring in such areas;
4. shall be instructed of their responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of the Act, these regulations, and licenses or unnecessary exposure to radiation or radioactive material;
5. shall be instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and
6. shall be advised when beginning this work, as necessary during employment, and your termination, as to the radiation exposure reports which workers shall be furnished pursuant to J.13.
The extent of these instructions shall be commensurate with potential radiological health protection problems in the restricted area.

Sec. J.13 Notifications and Reports to Individuals

Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in J.13. The information reported shall include data and results obtained pursuant to these regulations, orders, or license conditions, as shown in records maintained by the licensee or registrant pursuant to D.1107 of these regulations. Each notification and report shall:
1. be in writing;
2. include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably U_ID number;
3. include the individual's exposure information; and
4. contain the following statement:
  "This report is furnished to you under the provisions of COMAR 26.12.01.01 Part J. You should preserve this report for further reference."
Each licensee or registrant shall furnish a report to each worker annually and within 30 days following termination of the worker's dose as shown in records maintained by the licensee or registrant pursuant to D.1107 of these regulations.
Each licensee or registrant shall furnish a report of the worker's exposure to sources of radiation at the request of a worker formerly or presently engaged in activities controlled by the licensee or registrant. The report shall include the dose record for each year the worker was required to be monitored pursuant to D.502 of these regulations. Such report shall be furnished within 30 days from date the request was made, or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report shall cover the period of time that the worker's activities involved exposure to sources of radiation and shall include the dates and locations of work under the license or registration in which the worker participated during this period.
When a licensee or registrant is required pursuant to D.1203 of these regulations to report to the Agency any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a report on the exposure data included therein. Such reports shall be transmitted at a time not later than the transmittal to the Agency.
A licensee or registrant shall furnish to each worker who is terminating employment in work involving exposure to sources of radiation, a written report during the current year to each such worker, or to a worker's designee, regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose shall be provided together with a clear indication that this is an estimate.

Sec. J.14 Presence of Representatives of Licensees or Registrants and Workers During Inspection

Each licensee or registrant shall afford to the Agency, or an agent of the Agency licensed under COMAR 26.12.02.03, at all reasonable times opportunity to inspect materials, machines, activities, facilities, premises, and records pursuant to these regulations.
During an inspection, Agency inspectors, or agents of the Agency licensed under COMAR 26.12.02.03, may consult privately with workers as specified in J.15. The licensee or registrant may accompany Agency inspectors or agents etc. during other phases of an inspection.
If, at the time of inspection, an individual has been authorized by the workers to represent them during Agency inspections, the licensee or registrant shall notify the inspectors of such authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.
Each workers' representative shall be routinely engaged in work under control of the licensee or registrant and shall have received instructions as specified in J.12.
Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one workers' representative at a time may accompany the inspectors.
With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany Agency inspectors or agents of the Agency etc. during the inspection of physical working conditions.
Notwithstanding the other provisions of J.14, Agency inspectors or agents of the Agency etc. are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an agency of the U.S. Government in the interest of national security, an individual who accompanies an inspector may have access to such information only if authorized to do so. With regard to any area containing proprietary information, the workers' representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.

Sec. J.15 Consultation with Workers During Inspections

Agency inspectors or agents etc. or a State-licensed inspector performing an inspection under the authority of COMAR 26.12.01.02 may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of these regulations and licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.
During the course of an inspection, any worker may bring privately to the attention of the Agency inspector or agents etc., either orally or in writing, any past or present condition which the worker has reason to believe may have contributed to or caused any violation of the Act, these regulations, or license condition, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements of J.16(a).
The provisions of J.15(b) shall not be interpreted as authorization to disregard instructions pursuant to J.12.

Sec. J.16 Requests by Workers for Inspections

Any worker or representative of workers believing that a violation of the Act, these regulations, or license conditions exists or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged may request an inspection by giving notice of the alleged violation to the Agency. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the Agency no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the Agency, except for good cause shown.
If, upon receipt of such notice, the Agency determines that the complaint meets the requirements set forth in J.16(a), and that there are reasonable grounds to believe that the alleged violation exists or has occurred, an inspection shall be made as soon as practicable to determine if such alleged violation exists or has occurred. Inspections pursuant to J.16 need not be limited to matters referred to in the complaint.
No licensee, registrant, or contractor or subcontractor of a licensee or registrant shall discharge or in any manner discriminate against any worker because such worker has filed any complaint or instituted or caused to be instituted any proceeding under these regulations or has testified or is about to testify in any such proceeding or because of the exercise by such worker on behalf of such worker or others of any option afforded by this part.

Sec. J.17 Inspections Not Warranted; Informal Review

If the Agency determines, with respect to a complaint under J.16, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the Agency shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the Secretary of the Department of the Environment will provide the licensee or registrant with a copy of such statement by certified mail, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the Secretary of the Department of the Environment will provide the complainant with a copy of such statement by certified mail.
Upon the request of the complainant, the Secretary of the Department of the Environment may hold an informal conference in which the complainant and the licensee or registrant may orally present their views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. After considering all written and oral views presented, the Secretary of the Department of the Environment shall affirm, modify, or reverse the determination of the Agency and furnish the complainant and the licensee or registrant a written notification of the decision and the reason therefore.
If the Agency determines that an inspection is not warranted because the requirements of J.16(a) have not been met, the complainant shall be notified in writing of such determination. Such determination shall be without prejudice to the filing of a new complaint meeting the requirements of J.16(a).

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Excerpts from COMAR 26.12.01.01

Part B - Registration of Radiation Machine Facilities and Services

Part F - X Rays in the Healing Arts

Part H - Radiation Safety Requirements for Analytical X-Ray Equipment

Part I - Radiation Safety Requirements for Particle Accelerators

Part J - Notices, Instructions, and Reports tp Workers; Inspections

Part BRegistration of Radiation Machine Facilities and Services