Tenn. Comp. R. & Regs. 0400-20-06-.05

Current through October 22, 2024

Section 0400-20-06-.05 - MEDICAL X-RAY INSTALLATIONS

(1) Therapeutic x-ray installations.

(a) Requirements for equipment and facility:

1. The tube housing shall be of the therapeutic type.

2. Adjustable beam-limiting diaphragms, cones, or fixed diaphragms shall be provided to collimate the useful beam to the area under treatment.

3. Fixed diaphragms or cones used to collimate the useful beam shall be so constructed as to provide the same degree of protection as the tube housing.

4. Adjustable beam-limiting diaphragm or cones shall not transmit more than 5 percent of the useful beam at the maximum kilovoltage and with the maximum treatment filter.

5. The radiation escaping through the filter slots shall not exceed an exposure rate of 1 R/hr at a distance of 1 meter or if the radiation from the slot is accessible to the patient, 30 R/hr at 5 centimeters from the external opening. Each removable filter shall be marked with its thickness and material.

6. The x-ray tube shall be secured so that it cannot move in respect to the aperture. A mark on the housing shall show the location of the focal spot.

7. A device shall be provided to immobilize the tube housing during stationary portal treatment.

8. A device shall be provided to terminate the exposure automatically after a preset time interval or preset exposure or dose limit. Means shall be provided for the operator to terminate the exposure at any time.

9. A filter indicator system shall be used on all therapy x-ray apparatus using changeable filters. It shall indicate from the control panel the presence or absence of any filter and it shall be designed to permit recognition of the filter in place. Color coded filters that are visible from the control panel qualify as an adequate indicator system.

10. Interlocks shall be provided so that when any door of the treatment room is opened either the x-ray apparatus will shut off automatically or the radiation exposure level within the room will be reduced to an average of not more than 2 milliroentgens per hour and an maximum of 10 milliroentgens per hour at a distance of 1 meter in any direction from the target. After such shut-off or reduction in output it shall be possible to restore the x-ray apparatus to full operation only from the control panel. For equipment operating at or below 60 kVp interlocks are not required.

11. The treatment room shall be so constructed that persons within the room may at all times be able to escape.

12. A visible signal which is actuated during the time x-rays are being generated shall be located outside and near each door to the treatment room.

13. There shall be on the control panel a device which indicates to the operator whether or not the tube is energized.

14. In the therapeutic use of x-ray apparatus constructed with windows of beryllium, or other material having an aluminum equivalent half-value layer less than 0.5 millimeter, the registrant shall use extreme care to insure that the unfiltered radiation reaches only that area of the patient intended and that the beam port is blocked at all times except when actually being used.

15. For contact therapy apparatus, the leakage radiation exposure at 5 centimeters from the surface of the tube housing shall not exceed 100 milliroentgens per hour.

(b) Conditions of operation:

1. The output of each therapeutic x-ray apparatus shall be calibrated by a qualified individual. The calibration shall be repeated after any change in or replacement of components of the x-ray generating equipment that could cause a change in x-ray output. Check calibrations shall be made at least once a year thereafter. Records of all calibrations shall be maintained by the registrant for inspection by the Division.

2. When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used whenever feasible. If the patient must be held by an individual, the individual shall wear a protective apron and he shall be positioned so that no part of his body will be struck by the useful beam and his body is as far as possible from the edge of the useful beam and his exposure shall be monitored and a record of such monitoring maintained for inspection by the Division. No pregnant women or persons under 18 years of age shall be used for this purpose.

3. Both the patient and control panel shall be under observation by the operator during patient irradiation.

4. All new installations and existing installations not previously surveyed shall have a radiation survey made by a qualified individual or registered inspector for the applicable class of x-ray unit. This shall be done after any change in the installation that might produce radiation levels in excess of those permitted by these regulations. Inadequacies found during the survey shall be corrected. A record of these surveys shall be kept on file for inspection by the Division.

5. Lead rubber, lead foil, or any other material used for limiting the treatment field shall transmit not more than 5 percent of the useful beam as measured when the maximum treatment filter for which the x-ray unit has been calibrated is in place.

6. Provision shall be made for oral communication with the patient from the control area.

7. No one other than the patient shall be in treatment room during treatment except as allowed in part 2. of this subparagraph except that for equipment operating at or below 60 kVp the operator and other persons may be permitted in the room during treatment provided that all such persons utilize protective aprons or their equivalent.

(2) Medical diagnostic x-ray installations.

(a) General requirements. Equipment:

1. The primary beam shall not be larger than clinically necessary. Cones, diaphragms, or adjustable collimators capable of restricting the primary beam to the area of clinical interest or an area within the limits imposed by the following conditions, whichever area is smaller, shall be used. The x-ray field size in the plane of the image receptor, whether controlled by cones, diaphragms, or adjustable collimators shall be such that neither the length nor the width of the x-ray field exceeds that of the image receptor by greater than 3 percent of the source-image receptor distance (SID) and that the sum of the length and width excesses be no greater than 4 percent of the SID when the equipment indicates that the beam axis is perpendicular to the place of the image receptor². Cones, diaphragms, or adjustable collimators used to restrict the primary beam shall provide the same degree of protection as is required in the tube housing.

(i) Except when contraindicated for a particular diagnostic procedure, the aluminum equivalent of the total filtration (inherent plus added) in the useful beam shall not be less than that shown in Table RHS 3-1.

Table RHS 3-1 FILTRATION REQUIRED VS. OPERATING VOLTAGE

Operating voltage (kVp)	Total filtration (millimeters) Al equivalent
Below 50	0.5
50 - 70	1.5
Above 70	2.5

(ii) If the thickness of the filter in the x-ray apparatus cannot be determined visually or the total filtration is unknown, it may be assumed that the requirements of subpart (i) of this part are met if the half-value layer is not less than that shown in Table RHS 3-2.

Table RHS 3-2 HALF-VALUE LAYER VS. OPERATING VOLTAGE

Design operating range (kilovolts peak) (kVp)	Measured potential (kVp)	Half-value layer (millimeters of aluminum)
Below 50	30	0.3
	40	0.4
	49	0.5
50 to 70	50	1.2
	60	1.3
	70	1.5
Above 70	71	2.1
	80	2.3
	90	2.5
	100	2.7
	110	3.0
	120	3.2
	130	3.5
	140	3.8
	150	4.1

(iii) For capacitor energy storage equipment, compliance shall be determined with the maximum quantity of charge per exposure.

(iv) For fluoroscopic equipment, the HVL measurement shall include the filtration contributed by the tabletop if the tabletop is placed permanently between the patient and the source.

3. The x-ray tube housing shall be of diagnostic type.

4. 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 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.

5. The radiation emitted by a component other than the diagnostic source assembly shall not exceed 2 milliroentgens 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.

6. Hand or head held fluoroscopic screens shall not be used.

7. Machines equipped with beryllium window x-ray tubes shall contain keyed filter interlock switches in the tube housing that activate a device on the control panel that indicates the added filter in the useful beam if the total filtration permanently in the useful beam is less than 0.5 millimeter aluminum equivalent. The total filtration permanently in the useful beam shall be indicated on the tube housing.

8. Beryllium window x-ray tubes shall not be used on multi-purpose radiographic equipment.

9. On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

10. On installations made after March 1, 1978, where two or more tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control and at or near the tube housing assembly that has been selected.

11. (Reserved)

12. Tube housing assemblies shall be equipped with a means to assure mechanical support of the housing during exposures without drift or vibration.

13. Where cones or diaphragms are used as beam-limiting devices, each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed.

14. In addition to other applicable requirements of this Chapter, diagnostic x-ray equipment certified under the Federal standards promulgated by the Department of Health and Human Services, in the Federal Register shall meet the following requirements:

(i) Each registrant shall retain, and shall present to the Division for examination when requested, all information provided by the manufacturer to the purchaser in accordance with the requirements of the applicable Federal standard and shall transfer this information to the subsequent owner of the equipment. See Rule 0400-20-06-.09, APPENDIX A.

(ii) Each registrant should keep a record of all maintenance and modifications performed on each diagnostic x-ray system containing any components certified under the applicable Federal standard during the period it is under his control, and, if kept, shall be transferred to the subsequent owner of the equipment.

(iii) No deviation from the requirements of these regulations will be considered a violation of these regulations if such deviation is permitted by a variance granted by the Food and Drug Administration, Department of Health and Human Services, or by a regulation promulgated pursuant to Public Law 90-602.

(b) General requirements. Operation of equipment:

1. Patient or film holding

(i) Except where clinically contraindicated, restraining devices or mechanical supporting devices shall be used.

(ii) No person under eighteen (18) years of age and no pregnant women shall be used.

(iii) No individual shall be used on a consistent or routine basis.

(iv) Protective gloves and aprons with at least 0.25 millimeters of lead equivalency shall be provided and their use required of each person used for this purpose.

(v) No part of the body of the person utilized for this purpose shall be in the primary beam unless protected by 0.5 millimeter of lead equivalent material.

(vi) If occupationally exposed persons are utilized their exposure shall be monitored.

2. (Reserved)

3. Other than the patient being examined no one will be allowed in the room during the radiographic exposure unless:

(i) The location of all individuals in the room shall be such that no part of the body including the extremities not protected by 0.5 millimeter lead equivalent will be struck by the useful beam.

(ii) Staff and ancillary personnel shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeters lead equivalent.

(iii) Other patients in the room shall be protected from the direct scatter radiation by whole body protective barriers of 0.25 millimeters 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.

(c) Radiographic installations (includes photofluorographic units).

1. The operator shall be able to see the patient and the control panel at all times during an exposure.

2. Radiographic equipment equipped with adjustable collimators shall contain light localizers that define the entire x-ray field. The size of the light field in the plane of the image receptor shall be such that no dimension of the light field differs from that of the x-ray field by greater than 2 percent of the SID when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor. The center of the light field shall be aligned with the center of the x-ray field to within 2 percent of the SID when the equipment indicates that the beam axis perpendicular to the plane onto which the x-ray and light fields are projected. See part (2)(a)1. of this rule for definition of length and width. The collimator shall also be equipped with a field size indicator that indicates numerically the dimensions of the x-ray field at the source-image receptor distances (SIDs) for which it is designed. Such numerical indication shall not deviate from the actual dimensions of the x-ray field at the SID by more than 2 percent of the SID when the equipment indicates that the axis of the beam is perpendicular to the plane of the image receptor. For equipment utilized in a manner that precludes the necessity of numerical indicators they shall not be required.

3. (Reserved)

4. 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.

5. Radiation Exposure Control Devices.

(i) 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.

(I) Termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero.

(II) 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.

(ii) X-Ray Control

(I) A control shall be incorporated into each x-ray system such that an exposure can be terminated at any time except for:

I. Exposure of one-half second or less, or

II. During serial radiography when means shall be provided to permit completion of any single exposure of the series in process.

(II) Each x-ray control shall be located in such a way as to meet the following criteria:

I. For stationary x-ray systems, the control shall be permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure, or

II. For mobile and portable x-ray systems, a method of control shall be provided that will permit the operator to stand at least 2 meters from the patient, primary beam, and tube head assembly.

(iii) Automatic Exposure Controls (Photo timers). When an automatic exposure control is provided:

(I) A device shall be on the control panel that indicates when this mode of operation is selected;

(II) When 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;

(III) The minimum exposure time for all other equipment shall be equal to or less than 1/60 second or a time interval required to deliver 5 mAs, whichever is greater;

(IV) 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 when the x-ray tube potential is less than 50 kVp in which case the product of x-ray tube current and exposure time shall be limited to not more than 2000 mAs per exposure; and

(V) A visible signal shall indicate when an exposure has been terminated at the limits described in item (IV) of this subpart, and manual resetting shall be required before further automatically timed exposures can be made.

(iv) The exposure shall be reproducible. When 4 exposures are made at identical technique factors the value of the average exposure (^E) shall be greater than or equal to 5 times the difference between the maximum exposure (E_max) and the minimum exposure (E_min), i.e.,

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(v) The timer shall be reproducible. When 4 timer tests are performed with a timer setting of 0.5 seconds or less, the average time period (^T) shall be greater than or equal to 5 times the difference between the maximum period (T_max) and the minimum period (T_min), i.e.,

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6. Radiation emitted from the x-ray tube of Capacitor Energy Storage Equipment when the exposure switch or timer is not activated shall not exceed a rate of 2 milliroentgens per hour at 5 centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.

7. For stationary general purpose x-ray systems means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within 2 percent of the SID, and to indicate the SID to within 2 percent.

(d) Fluoroscopic installations.

1. The source to skin distance shall not be less than 30.5 centimeters on stationary equipment installed or reinstalled before July 1, 1972, and shall not be less than 38 centimeters on stationary equipment installed or reinstalled thereafter. The source to skin distance shall not be less than 30.5 centimeters on all mobile fluoroscopes. For image intensified fluoroscopes used for specific surgical applications a source to skin distance of 20 centimeters will be allowed provided the user's operating procedures indicate precautionary measures to be adhered to during this device's use and provided that these precautionary measures are followed by the registrant or his representative.

2. Equipment shall be so constructed that the entire cross-section of the useful beam is attenuated by a primary barrier permanently incorporated into the equipment. The tube mounting and the barrier shall be so linked together that the barrier always intercepts the beam. This barrier is usually the viewing device, either a conventional fluoroscopic screen or an image intensification mechanism.

3. The required lead equivalent of the primary barrier shall be at least 1.5 millimeters for 100 kVp, 1.8 millimeters for 125 kVp, and 2.0 millimeters for 150 kVp. This requirement may be assumed to have been met if the exposure rate due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the image intensifier, if provided, does not exceed 2 milliroentgens per hour at 10 centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen per minute of entrance exposure rate³.

4. Collimators shall be provided to restrict the size of the useful beam to less than the area of the primary barrier. For conventional fluoroscopes, this requirement is met if, when the adjustable diaphragm is opened to its fullest extent, an unilluminated margin is left on the fluorescent screen with the screen properly centered in the beam at a distance of 38 centimeters from the panel or tabletop. Collimators shall provide the same degree of protection as is required in the x-ray tube housing. For image intensifiers, the useful beam shall be centered on the input phosphor within ± 2 percent of the SID and during fluoroscopy or cine-recording it should not exceed the diameter of the input phosphor. Means shall be provided by stepless adjustment to reduce the x-ray field size to 5 by 5 centimeters or less at the maximum SID.

5. For fluoroscopy, the radiation exposure as measured at the minimum target to skin distance shall be as low as practicable and shall not exceed 10 roentgens per minute except where clinically indicated. In cine-radiography, the exposure rates to which patients are normally subjected shall be determined periodically. An adequate period for such measurement shall be annually or after any change in the system that might affect the exposure rate. See subpart 13.(i) of this subparagraph for information on measuring exposure rate.

6. The registrant shall provide protective aprons, and shall require their use by the physician, nurse, technician, and for all other persons within the fluoroscopic room, except the patient.

7. The registrant shall provide protective gloves, and shall require their use by the fluoroscopist during any procedure in which the fluoroscopist may be required to approach the primary beam with his hand or hands.

8. Conventional fluoroscopic screens shall not be used with mobile fluoroscopic equipment. Image intensification shall always be provided, and in the absence of a table top or panel, a cone or spacer frame shall limit the target to skin distance to not less than 30.5 centimeters.

9. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the fluoroscopist for the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.

10. A cumulative timing device actuated by the exposure switch shall be used that will indicate elapsed exposure time by either interrupting the production of x-rays or by emitting a continuous audible warning signal when the total exposure time exceeds a pre-determined limit not exceeding 5 minutes in one or a series of exposures.

11. Fluoroscopic table designs when combined with procedures utilized shall be such that no part of any staff or ancillary person's body shall be exposed to unattenuated direct scattered radiation that originates from under the table. The attenuation required shall be at least equivalent to that of 0.25 millimeters of lead.

12. Equipment configuration when combined with procedures shall be such that no portion of any staff or ancillary person's body except the extremities shall be exposed to the unattenuated direct scatter radiation emanating from above the table top unless that individual is at least 2 meters from the center of the useful beam. This requirement cannot be met only by wearing a protective apron. Exceptions to this requirement may be made in some special procedures. The attenuation required here shall be at least equivalent to that of 0.25 millimeters of lead, (e.g., drapes, folding panel, or self-supporting curtains).

13. Additional requirements applicable to certified systems only.

(i) The exposure rate measured at the point where the center of the useful beam enters the patient shall not exceed 10 roentgens per minute for equipment incorporating automatic exposure control or 5 roentgens per minute for equipment not incorporating automatic exposure control except during recording of fluoroscopic images or when provided with optional high level control. When provided with optional high level control, the equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 5 roentgens per minute at the point where the center of the useful beam enters the patient unless the high level control is activated.

(I) Special means of activation of high level controls, such as additional pressure applied continuously by the operator, shall be required to avoid accidental use.

(II) A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.⁴

(ii) For image intensified fluoroscopy, neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed 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. Compliance shall be determined with the beam axis perpendicular to the image receptor. For rectangular x-ray fields used with circular image reception, the error in alignment shall be determined along with the length and width dimensions of the x-ray field that pass through the center of the visible area of the image receptor.

(iii) For spot filming, in addition to other requirements of this section:

(I) 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 that 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.

(II) 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 at the greatest SID shall be equal to or less than 5 by 5 centimeters.

(III) 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.

(iv) During fluoroscopy and cine-fluorography, x-ray tube potential and current shall be continuously indicated.

(3) Dental radiographic installations.

(a) Extra-oral dental radiographic equipment shall be considered medical radiographic equipment for the purposes of these regulations.

(b) A device shall be used for collimating the primary beam and shall provide the same degree of protection as the tube housing. For intra-oral radiography, the primary beam, as measured at the point where it strikes the patient's face, shall be as small as clinically possible and not more than 7.6 centimeters in diameter. Collimating devices designed to provide rectangular collimation of the primary beam to the size of the dental film should be considered for use when practicable.

(c) X-ray apparatus designed for intra-oral radiographic use shall be provided with means to limit the target to skin distance to not less than 18 centimeters if operable above 50 kVp or 10 centimeters if not operable above 50 kVp.

(d) Unless operating intraoral dental radiographic equipment designed to be operated as a hand-held device pursuant to subparagraph (3)(r) of this rule, no one except the patient should be in the room when X-ray exposures are made. If for some reason it is necessary for operating personnel to be in the room with the patient during exposures, an exposure cord shall be provided that is sufficiently long to permit operating personnel to stand at least two meters from the patient and the tube head and in an area of minimal exposure to scattered and leakage radiation and outside of the primary beam.

(e) 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.

1. The exposure shall be reproducible. When 4 exposures are made at identical technique factors the value of the average exposure (^E) shall be greater than or equal to 5 times the difference between the maximum exposure (E_max) and the minimum exposure (E_min), i.e.,

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2. When a timer is provided it:

(i) Shall terminate the exposure after a preset time. This preset time shall be only that time necessary for a single exposure.

(ii) Shall be reproducible. When 4 timer tests are performed with a timer setting of 0.5 seconds or less, the average time period (^T) shall be greater than or equal to 5 times the difference between the maximum period (T_max) and the minimum period (T_min), i.e.,

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(f) X-ray control (exposure switch)

1. A control shall be incorporated into each x-ray system such that an exposure can be terminated at any time, except for exposures of one-half second or less. A dead-man type control is preferred.

2. This control shall cause an exposure only if the timer or automatic exposure control has been preset.

3. During serial radiography, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in progress.

(g) Unless operating intraoral dental radiographic equipment designed to be operated as a hand-held device pursuant to subparagraph (3)(r) of this rule, neither the tube housing nor the Position Indicating Device may be hand held during an exposure.

(h) The film shall be held by an appropriate device or by the patient when an x-ray is made, or if necessary, by some other person not occupationally exposed to radiation. The fastest dental film available should be used.

(i) Fluoroscopic screens shall not be used.

(j) Filtration

1. Except when contraindicated for a particular diagnostic procedure, the aluminum equivalent of the total filtration (inherent plus added) in the useful beam shall not be less than that shown in Table RHS 3-3.

Table RHS 3-3 FILTRATION REQUIRED VS. OPERATING VOLTAGE

Operating voltage (kVp)	Total	filtration Al	(millimeters equivalent)
Below 50	0.5
50 - 70	1.5
Above 70	2.5

2. If the thickness of the filter in the x-ray apparatus cannot be determined visually or the total filtration is unknown, it may be assumed that the requirements of part 1. of this subparagraph are met if the half-value is not less than that shown in Table RHS 3-4.

Table RHS 3-4 HALF-VALUE LAYER VS. OPERATING VOLTAGE

Design operating range (kilovolts peak) (kVp)	Measured potential (kVp)	Half-value layer (millimeters of Al equivalent)
Below 50	30	0.3
	40	0.4
	49	0.5
50 to 70	50	1.2
	60	1.3
	70	1.5
Above 70	71	2.1
	80	2.3
	90	2.5
	100	2.7
	110	3.0
	120	3.2
	130	3.5
	140	3.8
	150	4.1

3. For capacitor energy storage equipment, compliance shall be determined with the maximum quantity of charge per exposure.

(k) The x-ray tube housing shall be of the diagnostic type.

(l) 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 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.

(m) The radiation emitted by a component other than the diagnostic source assembly shall not exceed 2 milliroentgens 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.

(n) Where 2 or more tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control and at or near the tube housing assembly that has been selected.

(o) (Reserved)

(p) Tube housing assemblies shall be equipped with a means to assure mechanical support of the housing during exposures without drift or vibration.

(q) In addition to other applicable requirements of this Chapter, diagnostic x-ray equipment certified under the Federal Standards promulgated by the Department of Health and Human Services in the Federal Register shall meet the following requirements:

1. Each registrant shall retain, and shall present to the Division for examination when requested, all information provided by the manufacturer to the purchaser in accordance with the requirements of the applicable Federal standard and shall transfer this information to the subsequent owner of the equipment. See Rule 0400-20-06-.09, APPENDIX A.

2. Each registrant shall keep a record of all maintenance and modifications performed on each diagnostic x-ray system containing any components certified under the applicable Federal standard during the period it is under his control, and transfer to the subsequent owner of the equipment.

3. No deviation from the requirements of these regulations will be considered a violation of these regulations if such deviation is permitted by a variance granted by the Food and Drug Administration, Department of Health and Human Services, or by a regulation promulgated pursuant to Public Law 90-602.

4. Radiographic systems designed for use with an intra-oral image receptor shall be provided with means to limit the x-ray beam such that:

(i) If the minimum source to skin distance (SSD) is 18 centimeters or more, the x-ray field shall be containable in a circle having a diameter of no more than 7 centimeters; and

(ii) If the minimum SSD is less than 18 centimeters, the x-ray field at the minimum SSD shall be containable in a circle have a diameter of no more than 6 centimeters.

5. Notwithstanding subparagraph (j) of this paragraph all dental x-ray systems manufactured on or after December 1, 1980, shall have a minimum half-value layer not less than 1.5 millimeters aluminum equivalent.

(r) The following requirements apply to any intraoral dental radiographic equipment designed to be operated as a hand-held device: ⁵

1. The registrant shall provide and require individual personnel monitoring of external occupational dose via a whole body dosimeter and extremity dosimeters for both the right and left hands to all persons who may operate the hand-held device. The registrant may be relieved of the requirement of this part after one year of personnel monitoring if the results of the personnel monitoring demonstrate that the operator of the hand-held device is not likely to receive a dose in excess of 10 percent of the limits in Rule 0400-20-05-.50, as outlined in Rule 0400-20-05-.71. The registrant shall maintain records of doses received by all individuals for whom monitoring was required pursuant to Rules 0400-20-05-.71 and 0400-20-05-.135.

2. Registrants shall implement security and accountability procedures to prevent unauthorized use, misuse, or unauthorized removal of the hand-held device from its storage location. Immediately after learning of an incident of unauthorized use, misuse, or unauthorized removal from its storage location, a registrant shall report the incident to the Division at the contact point identified in part (3)(a)1. of Rule 0400-20-05-.141. The registrant shall maintain records of the security and accountability procedures described in this part. Said records shall be made available for review by the Division.

3. The registrant shall ensure that:

(i) The operator prevents bystanders within a radius of at least six feet from the patient being examined with the hand-held device; and

(ii) Hand-held intraoral dental radiographic devices are not used for patient examinations in areas not designated as examination areas.

4. The registrant shall incorporate specific information regarding hand-held devices into any initial and recurring training provided to the facility staff. The training shall contain, at a minimum, the following:

(i) Training on the proper operation of the hand-held device;

(ii) The requirements listed in parts 1. through 3. of this subparagraph; and

(iii) Instructions provided by the manufacturer in regard to equipment with unique features as required under 21 CFR 1020.30(h)(1)(i).⁶

5. The registrant shall maintain records of the initial and recurring training provided to the facility staff described in part 4. of this subparagraph. Training records shall be made available for review by the Division and include:

(i) The date the training was provided;

(ii) The name of each individual trained (printed) and their signature;

(iii) The name and dated signature of the individual providing the training;

(iv) The topics covered in the training (or an attachment of the training material); and

(v) The duration of the training.

² For purposes of these regulations the length and width measurements will be made through the center of the x-ray field. The length measurement will be made at an angle of 90 degrees to the width measurement. Thus for circular beams the length and width will be equal to the diameter.

³ Compliance with this part will be determined as follows:

1. The exposure rate due to transmission through the primary barrier combined with radiation through the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

2. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.

3. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters.

⁴ Compliance with this item shall be determined as follows:

1. For all measurements, the attenuation block with 1/8 inches lead sheet shall be placed in the useful beam between the point of measurement of the entrance exposure rate and the input surface of the fluoroscopic imaging assembly. Bottom surface of the block shall be at least 10 centimeters from the point of measurement of the entrance exposure rate.

2. Movable grids and compression devices shall be removed from the useful beam during the measurement.

3. If the source is below the table, exposure rate shall be measured 1 centimeter above the tabletop or cradle.

4. If the source is above the table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

5. In a C-arm type of fluoroscope, the exposure rate shall be measured 30 centimeters from the input surface of the fluoroscopic imaging assembly.

⁵ This part is intended to apply to intraoral radiographic units that are hand-held. Any unit designed to be hand-held but operated as a fixed unit shall be subject to the requirements outlined in paragraph (3) of Rule 0400-20-06-.05.

⁶ "A unit that is hand-held constitutes a unique feature that requires manufacturers to describe any safety procedures and precautions necessary to reduce operator exposure." (See Guidance for Industry and FDA Staff - Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use, December 24, 2008, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Diagnostic Devices Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs.)

Tenn. Comp. R. & Regs. 0400-20-06-.05

Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed September 10, 2019; effective December 9, 2019. Amendments filed December 4, 2023; effective 3/3/2024.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.