Section 225.104. X-ray detection systems for explosives, weapons and illegal items

(a) This section applies to X-ray systems that produce an image that may be used to screen for the presence of explosive devices or components, weapons, contraband or prohibited items. This section does not apply to cabinet and baggage/package X-ray systems covered under § 225.101 (relating to cabinet X-ray systems and baggage/package X-ray systems).

(b) An X-ray system used for detection of explosives, weapons or illegal items may not be used on human beings or animals without specific permission of the Department. X-ray systems that irradiate human beings for medical diagnosis are covered under Chapter 221 (relating to human use of X-ray machines). X-ray systems that irradiate animals for diagnosis or therapy are covered under Chapter 223 (relating to veterinary medicine).

(c) Radiographic X-ray detection systems shall conform to the following:

(1) The leakage radiation from the source assembly measured at a distance of 1 meter in any direction from the source may not exceed 25.8 µc/kg (100 mR) 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.

(2) Portable X-ray systems shall be equipped with collimators which are capable of restricting the useful beam to the area of interest. Collimators shall provide the same degree of protection required in paragraph (1).

(3) A means shall be provided to terminate the exposure after a preset time, a preset to image receptor or a preset product of exposure time and tube current.

(4) The X-ray control shall have a dead-man type exposure switch.

(5) The X-ray controls shall indicate the technique factors, (that is, kilovoltage, tube current and exposure time or the product of tube current and exposure time).

(6) The X-ray machine shall be labeled with a readily discernible sign bearing the radiation symbol and the words, ‘‘CAUTION RADIATION—THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED’’ or words having a similar intent, near any switch that energizes the X-ray tube.

(7) For fixed radiographic equipment, an easily visible warning light shall be located adjacent to the X-ray tube and labeled with the words ‘‘X-RAY ON’’ or words having a similar intent. The warning light shall be illuminated only when the X-ray tube is energized or only when the shutter is open.

(d) Fluoroscopic X-ray detection systems shall conform to the following:

(1) The leakage radiation from the source assembly measured at a distance of 1 meter in any direction from the source may not exceed 25.8 µc/kg (100 mR) 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.

(2) The X-ray machine shall be labeled with a readily discernible sign bearing the radiation symbol and the words, ‘‘CAUTION RADIATION—THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED’’ or words having a similar intent, near any switch that energizes the X-ray tube.

(3) To the extent practicable, the X-ray system (X-ray tube, imaging system and the object being irradiated) shall be completely enclosed so that every location on the exterior meets conditions for an unrestricted area and the only access to the room or enclosure is through openings which are interlocked so that the radiation source will not operate unless all openings are securely closed and meet the requirements of 10 CFR 20.1601 (relating to control of access to high radiation areas).

(4) The equipment shall be constructed so that, under conditions of normal use, the entire cross-section of the useful beam shall be attenuated by a primary protective barrier permanently incorporated into the equipment.

(5) The X-ray control shall have a dead-man type exposure switch. Activation of the X-ray beam shall be possible only by continuous pressure on the exposure switch.

(6) An easily visible warning light shall be located adjacent to the X-ray tube or on the outside of the enclosure and be labeled with the words ‘‘X-RAY ON’’ or words having a similar intent. This light shall be illuminated only when the X-ray tube is energized or only when the shutter is open.

(e) Operating procedures for portable radiographic X-ray detection systems are as follows:

(1) To the extent practicable, portable X-ray tube heads shall be supported by a stand.

(2) To the extent practicable, supporting or positioning devices for the image receptor shall be used during radiation exposures.

(3) Individuals, other than those whose presence is necessary to conduct the X-ray procedure, shall be located at least 2 meters away from the X-ray tube and the object being irradiated during exposures.

(4) An individual may not be regularly employed to support the image receptor or object during radiation exposures.

(f) Operating procedures for fixed radiographic X-ray detection systems are as follows:

(1) A registrant shall test the safety and warning devices, including interlocks, at intervals not to exceed 12 months. Test records shall be maintained for inspection by the Department for 3 years after the test has been conducted.

(2) Safety or warning devices that do not function properly shall be repaired in a timely manner.

(3) If an X-ray detection system is required to be operated while in need of repair, procedures shall be modified to maintain the design level equivalent of safety or else the equipment may not be used.