6 Colo. Code Regs. § 1007-1-6.4

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1007-1-6.4 - Requirements for use of all diagnostic and interventional x-ray imaging systems

6.4.1 Administrative Controls.

6.4.1.1 In addition to the general requirements of 6.3, the requirements of 6.4 apply to all diagnostic and interventional x-ray imaging systems and associated facilities, except as provided by 6.7.5.1 for dental uses and 6.8.5.1 for veterinary uses.

Additional requirements specific to dental intra-oral, panoramic, cephalometric, and volumetric dental imaging equipment are included in Section 6.7.

6.4.1.2 Each individual who operates an x-ray imaging system used on living humans shall meet the applicable radiation safety training and experience requirements of Part 2, Section 2.6.1.

6.4.2 Each diagnostic x-ray imaging system shall meet the following equipment design and configuration requirements.

6.4.2.1 Warning Label.

(1) On systems manufactured on or before June 10, 2006, the control panel containing the main power switch shall bear this or an equivalent warning statement, or the warning statement in 6.4.2.1(2), legible and accessible to view:

"WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."

(2) On systems manufactured after June 10, 2006, the control panel containing the main power switch shall bear the warning statement, legible and accessible to view:

"WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."

6.4.2.2 Battery Charge Indicator.

(1) On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

6.4.2.3 Leakage Radiation from the Diagnostic Source Assembly.

(1) The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source shall not exceed 0.88 milligray (mGy) air kerma (100 milliroentgen (mR) exposure) in any 1 hour when the x-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly.

(2) Compliance shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm.

6.4.2.4 Radiation from Components Other Than the Diagnostic Source Assembly.

(1) The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of 18 microgray (µGy) (2 milliroentgens (mR) exposure) in any one hour at 5 cm from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed.

(2) Compliance shall be determined by measurements averaged over an area of 100 square centimeters (cm) with no linear dimension greater than 20 cm.

6.4.2.5 Beam Quality: Half-value Layer

(1) The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in Appendix 6I.

(2) If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Appendix 6I, linear interpolation or extrapolation is acceptable. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent x-ray emissions if the minimum required filtration is not in place.

(3) Optional filtration on fluoroscopic systems. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube(s) with a continuous output of 1 kilowatt or more and an anode heat storage capacity of 1 million heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions of 6.4.2.5. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.

(4) For capacitor energy storage x-ray equipment still in use, compliance with the applicable requirements of 6.4.2.5 shall be determined with the system fully charged and for the highest clinically used mAs.

(a) Due to reduced image quality and potential for higher patient exposures, capacitor energy storage x-ray equipment shall no longer be used for human patient imaging beyond January 1, 2022.

6.4.2.6 Tube Heads.

(1) The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.

(2) Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes that have been selected shall be clearly indicated prior to initiation of the exposure. Only the selected tube(s) can be energized.

(a) This indication shall be both on the x-ray control panel and at or near the tube housing assembly that has been selected.

(3) Information displayed at the tube housing assembly meet manufacturer's specifications.

6.4.2.7 Locks.

(1) All position locking, holding, and centering devices on the x-ray system and/or components shall function as intended.

6.4.2.8 The x-ray control shall provide:

(1) Visual indication observable at or from the operator's protected position whenever x-rays are produced; and

(2) A signal audible to the operator to indicate that the exposure has terminated.

6 CCR 1007-1-6.4

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