Statutes, codes, and regulations
Colorado Administrative Code
Department 1000 - Department of AgricultureDivision 1007 - Plant Industry DivisionRule 6 CCR 1007-1 - RULES AND REGULATIONS PERTAINING TO THE ADMINISTRATION AND ENFORCEMENT OF THE PESTICIDE APPLICATORS' ACTPart 02 - RADIATION CONTROL - REGISTRATION OF RADIATION MACHINES, FACILITIES AND SERVICES
CERTIFICATION EVALUATION
Section 6 CCR 1007-1-2.7 - Service Company Registrant Responsibilities

6 Colo. Code Regs. § 1007-1-2.7

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Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-2.7 - Service Company Registrant Responsibilities
2.7.1 No person shall certify or declare that a radiation machine or component is ready for its intended use, until:
2.7.1.1 The shielding design has been completed as required by 6.3.2, as documented by a comment on Form FDA 2579 (for machines used in the healing arts) or a signed and dated notification to the Department; and
2.7.1.2 The machine or component meets the manufacturer specifications and the requirements of these regulations; and
2.7.1.3 The registrant has been provided, by the vendor, assembler or services and servicing personnel, the following:
(1) All guidance documents, including instruction manuals, manufacturer specifications and information notices, that are applicable to each newly installed radiation machine system or component; and
(2) The Colorado x-ray facility registrant's responsibilities list, as posted on the department website.
2.7.2 Any person who sells, leases, transfers, lends, assembles, installs, trades out or repairs any radiation machine, or component, which affects radiation output or technique setting in this State shall notify the Department in writing within fifteen (15) calendar days of each transaction subject to this section with the following information:
2.7.2.1 The full name and address of each person who has received the radiation machine or component and the specific location within the facility; and
2.7.2.2 Specific details about the system or sub-system, including the manufacturer, model, and serial number of each radiation machine or component transferred; and
2.7.2.3 The date of transfer, assembly, or installation of each radiation machine or component; and
2.7.2.4 A completed Form FDA 2579 or a signed and dated affirmation that all instruction manuals, written instructions and regulations applicable to the newly installed radiation machine system or components have been delivered to the registrant.
2.7.3 A report of assembly (Form FDA 2579 or equivalent) shall be submitted to the Department within fifteen (15) calendar days following completion of the assembly or installation.
2.7.3.1 The assembly or installation is considered completed when the unit has properly been made operational and is ready for its intended use.
2.7.3.2 Form FDA 2579 or an equivalent report suffices in lieu of any reports required in 2.7.2.
2.7.4 As required by the Department on a Certification Evaluation Report, Form R 59-1, a service company technician who performs a radiation machine repair shall:
2.7.4.1 Sign the service repair certification section of the Certification Evaluation Report, Form R 59-1 issued by the qualified inspector who performed the evaluation; and
2.7.4.2 Provide a written detailed description of the service to the registered facility within one (1) business day.
2.7.5 A service technician who performs any activity that could potentially affect the radiation machine output, cause a change to the clinical technique settings of the radiation machine, or affect image quality shall provide a written detailed description of all service to the registered facility within one business day of the service.
2.7.6 Any person who disables a radiation machine in order to meet the requirements of 2.3.4 shall be registered with the Department as a Service Company.

6 CCR 1007-1-2.7

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