Code of Colorado Regulations
1000 - Department of Public Health and Environment
1007 - Hazardous Materials and Waste Management Division
6 CCR 1007-1 - RULES AND REGULATIONS PERTAINING TO THE ADMINISTRATION AND ENFORCEMENT OF THE PESTICIDE APPLICATORS' ACT
Part 24 - RADIATION CONTROL - PARTICLE ACCELERATORS AND THERAPEUTIC RADIATION MACHINES IN THE HEALING ARTS
SPECIFIC REQUIREMENTS
Section 6 CCR 1007-1-24.15 - Other Use of Electronically-Produced Radiation to Deliver Therapeutic Radiation Dosage
Universal Citation: 1000 CO Code Regs 6 CCR 1007-1-24.15
Current through Register Vol. 48, No. 6, March 25, 2025
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.
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