Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-7-F - Sealed Sources for Diagnosis7.40Use of sealed sources and medical devices for diagnosis.7.40.1 A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the Sealed Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.7.40.2 A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry.7.40.3 Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration provided the requirements of 7.14.1 are met.7.40.4 Training for use of sealed sources and medical devices for diagnosis. The licensee shall require an authorized user under 7.40 to meet the requirements of Appendix 7J.
Colorado Register, Vol 37, No. 14. July 25, 2014, effective 8/14/201438 CR 02, January 25, 2015, effective 2/14/201538 CR 05, March 10, 2015, effective 3/30/201538 CR 12, June 25, 2015, effective 7/15/201538 CR 14, July 25, 2015, effective 8/14/201539 CR 02, January 25, 2016, effective 2/14/201639 CR 16, August 25, 2016, effective 9/14/201639 CR 22, November 25, 2016, effective 12/15/201640 CR 11, June 10, 2017, effective 6/30/201740 CR 20, October 25, 2017, effective 11/14/201742 CR 24, December 25, 2019, effective 1/14/202043 CR 14, July 25, 2020, effective 8/14/202043 CR 18, September 25, 2020, effective 10/15/202044 CR 11, June 10, 2021, effective 7/15/202144 CR 14, July 25, 2021, effective 8/14/202145 CR 22, November 25, 2022, effective 12/15/2022