6 Colo. Code Regs. § 1007-1-8.2

Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-8.2 - Definitions
8.2.1 Definitions of general applicability to these regulations are in Part 1, Section 1.2.
8.2.2 As used in Part 8, each term below has the definition set forth.

"Accessible surface" means the external or outside surface of the enclosure or housing provided by the manufacturer. This includes high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across the exterior edge of any opening.

"Analytical x-ray equipment" means equipment that generates (by electronic means) and uses ionizing radiation for the purpose of examining the microstructure of materials, i.e., diffraction and spectroscopy (including fluorescence).

"Baggage unit". See "Security Screening Unit".

"Beam-port" means an opening on the x-ray apparatus designed to emit a primary beam. This does not include openings on baggage units.

"Cabinet radiography" means industrial radiography using radiation machines not subject to FDA 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:

A. The radiation machine will not operate unless all openings are closed with interlocks activated;
B. The cabinet is shielded such that every location on the exterior meets the conditions for an unrestricted area as defined in Part 4 of these regulations; and
C. The cabinet is constructed or arranged as to exclude the entrance of any part of the body of an individual during irradiation.

"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 bags, packages, and personal items at airline, railroad, and bus terminals, and at other facilities for similar purposes. 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.

"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 1020.10.

"Certified cabinet x-ray system" means a 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 1020.40.

"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.

"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.

"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.

"Collimator" means a device for restricting the useful radiation in one or more directions.

"Control panel" means a device containing means for regulation and activation of a RGD or for the preselection and indications of operating factors.

"Emergency procedure" means the written pre-planned steps to be taken in the event of actual or suspected exposure of an individual in excess of administrative or regulatory limits. This procedure shall include the names and telephone numbers of individuals to be contacted as well as directives for processing the film badge or other personnel monitoring devices.

"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. For example, if a light indicating "X-RAY ON" fails, the production of x-rays shall be prevented, or if a shutter status indicator fails, the shutter shall close.

"General-use system" means a human body screening system that delivers an effective dose equal to or less than 25 µrem (0.25 µSv) per screening. Given proper justification and certain restrictions, general-use systems may be operated without specific controls that would limit the number of individuals scanned or the number of scans per individual in a year.

"Hand-held x-ray system" means a portable instrument that is designed to operate when held in the hand, such as a hand-held x-ray fluorescence (XRF) analytical device.

"Human body security screening system" means any x-ray equipment used on humans for security evaluation purposes.

"Industrial radiography" means an examination of the structure of materials by nondestructive methods utilizing ionizing radiation to make radiographic images for the purpose of detecting structural flaws in objects. Industrial radiography does not include such imaging for education or research purposes at a fixed location.

"Interlock" means a device or engineered system that precludes access to an area of radiation hazard either by preventing entry or by automatically removing the hazard.

"Leakage radiation" means all radiation coming from within the source housing, except the useful beam.

"Limited-use system" means a human body screening system that is capable of delivering an effective dose greater than 25 µrem (0.25 µSv) per screening but cannot exceed an effective dose of 1 mrem (10 µSv) per screening. Limited-use systems require additional controls and documentation to ensure that annual individual dose limits required by 8.11.5 are not exceeded. "Local components" means parts of a RGD x-ray system and include areas that are exposed to x-rays, such as radiation source housings, beam 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.

"Mobile equipment". See "Radiation generating device."

"Normal operating procedures" means a set of step-by-step instructions necessary to accomplish the task. These procedures may include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant, and data recording procedures, which are related to radiation safety.

"Open-beam x-ray equipment" means an open-beam x-ray system in which the beam path could be entered by any part of the body at any time.

"Portable equipment". See "Radiation generating device."

"Primary beam" means the ionizing radiation coming directly from the radiation source through a beam port into the volume defined by the collimation system.

"Qualified inspector" means an individual as defined in Part 1 of these regulations.

"Radiation generating device (RGD)" for purposes of Part 8, means any system, device, subsystem, or component thereof, which may generate x-rays or particle radiation between 5 keV and 1 MeV, and not intended for healing arts use for humans or animals. A RGD is x-ray equipment (as defined in Part 1 of the regulations) that may be mobile, portable, or stationary.

"Radiation Safety Officer (RSO)" means an individual as defined in Part 1 of these regulations.

"Radiation source (or x-ray tube) housing" means that portion of an x-ray system which contains the x-ray tube and/or secondary target. Often the housing contains radiation shielding material or inherently provides shielding.

"Radiograph" means a permanent film or digital image produced on a sensitive surface by a form of radiation other than direct visible light.

"Radiography" is the process of creating radiographic images.

"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 or that causes the beam to shut off upon entry into its path.

"Scattered radiation" means radiation that has been deviated in direction and / or energy by passing through matter.

"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.

"Shielded room" means a room housing a RGD where, with the RGD at maximum exposure setting, the exterior room environs meets the unrestricted area limits of 2 mrem (0.02 mSv) in any one hour and 100 mrem (1 mSv) in a year at 30 centimeters from the barrier. A shielded room does not include a RGD which meets the definition of cabinet x-ray systems.

"Shutter" means a moveable device used to block the useful (or primary) beam emitted from an x-ray tube assembly.

"Source" means the point of origin of the radiation, for example, the focal spot of an x-ray tube.

"Stationary equipment". See "Radiation generating device."

"Stray radiation" means the sum of leakage and scatter radiation.

"Warning device" means a visible or audible signal that warns individuals of a potential radiation hazard.

"X-ray generator" means that portion of an x-ray system which provides the accelerating high voltage and current for the x-ray tube.

"X-ray gauge" means an x-ray producing device designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, or interface location.

6 CCR 1007-1-8.2

Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/2014
38 CR 02, January 25, 2015, effective 2/14/2015
38 CR 05, March 10, 2015, effective 3/30/2015
38 CR 12, June 25, 2015, effective 7/15/2015
38 CR 14, July 25, 2015, effective 8/14/2015
39 CR 02, January 25, 2016, effective 2/14/2016
39 CR 16, August 25, 2016, effective 9/14/2016
39 CR 22, November 25, 2016, effective 12/15/2016
40 CR 11, June 10, 2017, effective 6/30/2017
40 CR 20, October 25, 2017, effective 11/14/2017
42 CR 24, December 25, 2019, effective 1/14/2020
43 CR 14, July 25, 2020, effective 8/14/2020
43 CR 18, September 25, 2020, effective 10/15/2020
44 CR 11, June 10, 2021, effective 7/15/2021
44 CR 14, July 25, 2021, effective 8/14/2021
45 CR 22, November 25, 2022, effective 12/15/2022