1. (a) Unless otherwise provided in this Part, this section applies to all RGDs and certified and certifiable cabinet x-ray systems, both of which shall also meet the requirements of 21 CFR 1020.40.

2. (b) Warning devices shall:

   1. (1) Be labeled so that their purpose is easily identified; and
   2. (2) Contain an easily visible warning light labeled with the words "X-RAY ON" or other words having a similar intent. This warning light shall be located near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized and be of a fail-safe design.

3. (c) All RGD equipment labeling shall include:

   1. (1) A readily visible and discernible sign or signs bearing the radiation symbol in accordance with He-P 4022.11 and the words: “CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED,” or words having a similar intent, near any

      switch that energizes an x-ray tube; and

   2. (2) For RGDs with designed openings for object entries such as baggage units, the following language shall be posted at or near each opening: “CAUTION – X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED”, or words having similar intent.

4. (d) Each x-ray tube housing shall be subject to the following requirements:

   1. (1) When the x-ray tube housing is the primary shielding for the x-ray tube, and is intended to be opened for normal use or maintenance, the housing shall be equipped with an interlock that shuts off the high voltage to the x-ray tube if the housing is opened; and
   2. (2) Each x-ray tube housing shall be so constructed that, with all shutters closed, the leakage radiation measured at a distance of 5 centimeters from the x-ray tube housing surface does not exceed 0.025 mSv (2.5 mrem) per hour. This limit shall be met at the maximum tube rating.
5. (e) Each x-ray generator or high-voltage source shall be supplied with a protective cabinet which limits leakage radiation to 2.5 µSv (0.25 mrem) per hour at a distance of 5 centimeters measured at the nearest accessible surface.
6. (f) For closed-beam systems, the requirements in He-P 4043.05(d)(2) and 4043.05(e) shall be met by complying with He-P 4043.08(e).
7. (g) For an RGD in a shielded room, the requirements in He-P 4043.05(d)(2) and 4043.05(e) shall be met by measuring from any accessible surface outside the room housing the RGD.
8. (h) For hand-held, open-beam RGDs, the requirements in He-P 4043.05(d)(2) and 4043.05(e) shall be met by complying with the limits in He-P 4043.10(c).

9. (i) Radiation surveys of all RGDs shall be sufficient to show compliance with radiation emission requirements of this Part, and as required by He-P 4020.05, entitled “Occupational Dose Limits for Adults” and He-P 4020.13, entitled “Dose Limits for Individual Members of the Public”. At a minimum, surveys shall be performed:

   1. (1) Upon installation of the equipment, and at least once every 12 months thereafter;
   2. (2) Following any change in the initial arrangement, number, or type of local components in the system;
   3. (3) Following any maintenance requiring the disassembly, removal, or repair of a local component in the system;
   4. (4) During the performance of maintenance, calibration, and other procedures if the procedures require the presence of a primary x-ray beam while any local component in the system is disassembled or removed;
   5. (5) Post bypass of a safety device or interlock as required by He-P 4043.06(a)-(f);
   6. (6) Any time a visual inspection of the local components in the system reveals an abnormal condition; and
   7. (7) Whenever a personnel monitoring device shows a significant increase over previous monitoring period or readings are approaching the limits specified in He-P 4020.05.
10. (j) Radiation survey measurements shall not be required if a registrant can otherwise demonstrate compliance with the requirements of this Part to the satisfaction of the department of health and human services radiological health section (DHHS/RHS).
11. (k) Each area or room containing an RGD where an individual might receive 0.02 mSv (2 mrem) in any one hour or 1 mSv (100 mrem) per year shall be conspicuously posted with a sign or signs bearing the radiation symbol and the words “CAUTION - X-RAY EQUIPMENT,” “CAUTION – RADIATION GENERATING DEVICE”, or words having a similar intent.
12. (l) RGDs shall be secured in such a way as to be accessible to, or operable by, only authorized personnel when not in operation.

Source. #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10804, eff 3-26-15; ss by #14336, eff 8-8-25, EXPIRES: 8-8-35