6 Colo. Code Regs. § 1007-1-6-D
6D.1 The operating condition of an radiation machine and related equipment shall not be such that the continued operation of that machine endangers the public health and safety.
6D.2 An radiation machine shall be considered unsafe for human, animal or other use if:
6D.2.1 The radiation machine system has a malfunctioning component or components that could result in an inadvertent exposure to members of the public, the operator, or the patient. Examples include but are not limited to: a timer that fails to terminate the exposure, an exposure switch when activated once produces multiple exposures, a system that produces x-rays without activation of the exposure switch.
6D.2.2 The radiation machine is not equipped with a means of determining when x-rays are in production.
6D.2.3 The radiation machine is equipped with variable exposure settings and the selectors and/or indicators of these exposure settings do not permit the operator to determine the factors in use or if the indicated versus the exposure settings are in error by fifty (50) percent or more, except for exposure times selected less than 50 millisecond.
6D.2.4 The collimation of the x-ray beam of a fluoroscopic/spot film system is such that either the length or width of the x-ray field in the plane of the image receptor differs (in excess) from the corresponding image receptor dimensions by more than 25 percent of the source to image distance (SID).
6D.2.5 The half-value layer of aluminum (or equivalent) filtration in the useful beam is more than fifty (50) percent below the values specified in 6.4.2.5.
6D.2.6 The quality of the imaging is significantly degraded such that significant additional exposures or imaging is needed to obtain an adequate image.
6D.2.7 In addition to the above items a fluoroscopic x-ray system will be considered unsafe if:
(1) In normal fluoroscopic mode:
(a) No operational image intensifier or direct digital image receptor is provided.
(b) Except for radiation oncology simulators, the primary protective barrier does not intercept 100 percent of the x-ray beam of a fluoroscopic x-ray system.
(c) Except for radiation oncology simulators, the fluoroscopic x-ray system is capable of producing x-rays when the primary protective barrier is not in position to intercept the beam.
(d) The fluoroscopic x-ray system has a tabletop AKR equal to or greater than 220 mGy per minute (25 R/min) at the point where the useful beam enters the patient, except:
(i) During the recording of fluoroscopic images, or
(ii) When an optional high-level control is activated.
(2) When using a high-level control, the equipment is operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (20 R/min), consistent with 21 CFR 1020.32(d)(2)(iii)(C).
6D.2.8 An electro-mechanical defect exists that endangers human life or safety when a radiograph is made or fluoroscopy is performed.
6 CCR 1007-1-6-D