1. (a) All open-beam configurations shall be provided with a safety 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.

2. (b) The registrant shall document their justification of the use of open-beam instead of

   closed-beam systems.

3. (c) If the registrant’s use of the open-beam RGD does not permit the use of a safety device to prevent direct body exposure the registrant shall document:

   1. (1) A description of the various safety devices that have been evaluated;
   2. (2) The reason each of these devices cannot be used;
   3. (3) A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure; and
   4. (4) The procedures followed to assure that operators and others in the area will be informed of the absence of safety devices.
4. (d) The registrant shall maintain documentation required by He-P 4043.09(c) for as long as those methods are employed plus an additional 5 years.
5. (e) For portable open-beam RGDs that are manufactured to be used hand-held, or potentially used as a hand-held, without such safety devices, this safety device requirement may be met by complying with all the requirements in He-P 4043.10 prior to use.
6. (f) All open-beam configurations shall contain a warning device.
7. (g) Each open-beam RGD shall have an easily visible warning light labeled with the words “X-RAY ON” located near any switch that energizes an x-ray tube.

8. (h) The warning device required in He-P 4043.09(f) shall:

   1. (1) Indicate the x-ray tube “on-off” status and be located near the radiation source housing, if the light required by He-P 4043.09(g) is not readily discernable and viewable by anyone near the primary beam; and
   2. (2) Indicate the shutter “open-closed” status at the control panel and near each beam port on the radiation source housing, if the primary beam is controlled by a shutter. A shutter “open-closed” status light at the control panel, alone, is adequate provided the light is readily discernable and viewable by anyone near the primary beam.
9. (i) The warning light required in He-P 4043.09(g) shall be illuminated only when the x-ray tube is energized.
10. (j) The warning light described in He-P 4043.09(h)(2) shall be illuminated only when the shutter is open.
11. (k) Any unused port on a radiation machine source housing shall be secured in the closed position in such a manner as to prevent casual opening.
12. (l) On open-beam RGD configurations that are designed to accommodate interchangeable components, each beam port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a component coupling has been connected to the beam port.
13. (m) The local components of an open-beam RGD shall be located and arranged, and shall include sufficient shielding or access control, such that no radiation emissions exist, exclusive of the primary beam, in any area surrounding the local component group which could result in a dose to an individual present in excess of the dose limits as outlined in He-P 4020.13. These emissions shall be met at any specified tube rating.
14. (n) In cases where the primary x-ray beam is not intercepted by the detector device under all conditions of operation, protective measures shall be provided, such as auxiliary shielding or administrative procedures, to avoid exposure to any individual from the transmitted primary x-ray beam.
15. (o) The operator shall be in immediate attendance at all times when the equipment is in operation except when the area is locked or the equipment is secured to protect against unauthorized or accidental entry.

16. (p) If the RGD is not in a restricted area, as defined in He-P 4003.01, the operator shall be able to control access to the RGD at all times during operation. If the RGD is not in a restricted area and the RGD is capable of creating a radiation area or a high radiation area, the operator shall be able to control access to the RGD at all times during operation, and:

    1. (1) Radiation areas shall be conspicuously identified. The radiation source shall be within a conspicuous perimeter, such as rope, tape, or other barrier, that identifies the area in which the dose equivalent rate exceeds 0.05 mSv (5 mrem) per hour. The area described by the temporary barricade shall be suitably posted with “CAUTION - RADIATION AREA” signs. The operator shall ensure that no one is inside or enters the radiation area during operation of the RGD;
    2. (2) High radiation areas shall be conspicuously identified. The radiation source shall be within a conspicuous perimeter, such as rope, tape, or other barrier, that identifies the area in which the dose equivalent rate exceeds 1 mSv (100 mrem) per hour. The area described by the temporary barricade shall be suitably posted with “CAUTION - HIGH RADIATION AREA” signs. The operator shall ensure that no one is inside or enters the high radiation area during operation of the RGD;
    3. (3) The operator shall perform a visual check of the controlled area to ensure it is free of all unauthorized personnel immediately prior to activating or exposing the radiation source;
    4. (4) Surveillance of the exposure area shall be maintained during operation, either by visual or by other reliable means to ensure that no person enters the area;
    5. (5) With the exception of hand-held x-ray systems, when approaching the radiation source, following the conclusion of an exposure, the operator shall use a suitable calibrated and operable radiation detection instrument to verify that the radiation source is in its fully shielded condition or that the x-ray tube has been de-energized;
    6. (6) Measurement of radiation levels for a radiation survey shall be performed using an appropriate calibrated radiation survey meter. A radiation survey meter shall also be used when there is potential for non-uniform exposure to personnel, such as might occur during machine maintenance or work in a RGD target area;
    7. (7) During the initial exposure, the radiation levels shall be measured around the perimeter of the controlled area. The perimeter shall be adjusted accordingly to meet the access control requirement for radiation areas or high radiation areas; and
    8. (8) The survey around the perimeter shall be made for each new operating condition and the perimeter adjusted accordingly. The area of operation shall be monitored periodically if radiation levels are variable.

17. (q) In addition to the requirements in He-P 4043.07, no individual shall be permitted to operate or maintain an open-beam RGD unless such individual has received more specific and detailed instruction in and demonstrated competence as to:

    1. (1) Sources and magnitude of common radiation exposure;
    2. (2) Units of radiation measurement;
    3. (3) Radiation protection concepts of time, distance, shielding, and as low as reasonably achievable (ALARA);
    4. (4) Procedures and rights of a declared pregnancy;
    5. (5) Regulatory requirements and area postings;
    6. (6) Worker, embryo/fetus, and public dose limits;
    7. (7) Proper use of survey instruments and dosimetry; and
    8. (8) The requirements of He-P 4043.09(a)-(e).
18. (r) Any individual working with or routinely working near and having potential for exposure to the primary beam of an open-beam RGD shall be provided with extremity dosimetry.
19. (s) Personnel maintaining RGDs shall be provided with extremity dosimetry 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.

Source. #14336, eff 8-8-25, EXPIRES: 8-8-35