6 Colo. Code Regs. § 1007-1-24.15

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 Dosage
24.15.1. 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; and
24.15.1.2 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.

6 CCR 1007-1-24.15

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