Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-24.15 - Other Use of Electronically-Produced Radiation to Deliver Therapeutic Radiation Dosage24.15.1. A person shall not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not appropriately regulated under any existing category of therapeutic radiation machine, until:24.15.1.1. The applicant or registrant has, at a minimum, provided the Department with: (1) A detailed description of the device and its intended application(s);(2) Facility design requirements, including shielding and access control;(3) Documentation of appropriate training for authorized user physician(s) and registered medical physicist(s)(4) Methodology for measurement of dosages to be administered to patients or human research subjects;(5) Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety(6) Radiation safety precautions and instructions; and(7) Other information requested by the Department in its review of the application; and24.15.1.2 The applicant or registrant has received written approval from the Department to utilize the device in accordance with the regulations and specific conditions the Department considers necessary for the medical use of the device.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