1. (a) “Analytical x-ray equipment” means equipment used for x-ray diffraction or fluorescence analysis.
2. (b) “Baggage unit” means a cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages, or other commodities or structure.
3. (c) “Beam-port” means an opening on the x-ray apparatus designed to emit a primary beam. This does not include openings on baggage units.
4. (d) “Bomb detection radiographic equipment” means x-ray generating equipment used solely for the purpose of remotely detecting explosive devices. This definition does not include hand-held x-ray bomb detection equipment for the purposes of this Part.

5. (e) “Cabinet radiography” means industrial radiography using radiation machines not subject to Food and Drug Administration performance standard for cabinet x-ray systems, in an enclosed, interlocked cabinet in which the portion of a material being irradiated is contained, and in which:

   1. (1) The radiation machine will not operate unless all openings are closed with interlocks activated;

   2. (2) The cabinet is shielded such that every location on the exterior meets the conditions for an

      unrestricted area as defined in He-P 4003.01(fs); and

   3. (3) The cabinet is constructed or arranged as to exclude the entrance of any part of the body of an individual during irradiation.
6. (f) “Cabinet x-ray system” means an x-ray system with the x-ray tube installed in an enclosure which, independently of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of x radiation. Included are all x-ray systems designed primarily for the inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An x-ray tube used within a shielded part of a building, or x-ray equipment which may temporarily or occasionally incorporate portable shielding, is not a cabinet x-ray system.
7. (g) “Cathode ray tube” means any device used to accelerate electrons for demonstration or research purposes, except where such cathode ray tube is incorporated into a television or display monitor that is subject to, and has met applicable federal radiation safety performance standards in 21 CFR 1010 and 21 CFR 1020.10.
8. (h) “Certified cabinet x-ray system” means a radiation generating device (RGD) certified by the manufacturer in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of applicable federal radiation safety performance standards 21 CFR 1010 and 21 CFR 1020.40.
9. (i) “Certifiable cabinet x-ray system” means an existing uncertified RGD that has been modified to meet the certification requirements specified in 21 CFR 1020.40.
10. (j) “Closed-beam x-ray equipment” means a system in which the beam path cannot be entered by any part of the body during normal operation.
11. (k) “Cold-cathode gas discharge tube” means an electronic device in which electron flow is produced and sustained by ionization of contained gas atoms and ion bombardment of the cathode.
12. (l) “Electron microscope” means electronic equipment that produces radiation incidental to its operation and which is not exempt from registration under the provision of He-P 4040.05(a). The term includes “transmission electron microscope” and “scanning electron microscope”.
13. (m) “Fail-safe design” means a design in which all realistically anticipated failures of indicators or safety components result in a condition in which individuals are safe from exposure to radiation.
14. (n) “General-use system” means a personnel screening system that delivers an effective dose equal to or less than 0.25 μSv (25 μrem) per screening.
15. (o) “Hand-held x-ray system” means a portable instrument that is designed to operate when held in the hand, such as hand-held XRF analtytical devices.
16. (p) “Limited-use system” means a personnel screening system that is capable of delivering an effective dose greater than 0.25 μSv (25 μrem) per screening but cannot exceed an effective dose of 10 μSv (1 mrem) per screening.
17. (q) “Local components” means parts of an RGD and includes 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.
18. (r) “Normal operating procedures” means step-by-step instructions necessary to accomplish the analysis. These procedures include sample insertion and manipulation, device alignment, routine maintenance by the registrant or licensee, and data recording procedures, which are related to radiation safety.
19. (s) “Open-beam configuration” means an open-beam x-ray system in which an individual could accidentally place some part of their body in the primary beam path during normal operation.
20. (t) “Radiation generating device (RGD)” means any system, device, subsystem, or component thereof, which generate x-rays or particle radiation between 5 keV and 1 MeV, and is not intended for healing arts use for humans or animals.
21. (u) “Safety device” means a device, interlock, or system that 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.
22. (v) “Security screening unit” means a non-human use open-beam or cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages, or other commodities or structure.
23. (w) “Shielded room” means a room housing an RGD where, with the RGD at maximum techniques, the exterior room environs meets the unrestricted area limits of 0.02 mSv (2 mrem) in any one hour and 1 mSv (100 mrem) in a year at 30 cm from the barrier. A shielded room does not include an RGD which meet the definition of cabinet x-ray systems.
24. (x) “X-ray gauge” means a radiation generating device designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density level, or interface location.

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