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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 1007-1-2.5 - Certification Evaluations

6 Colo. Code Regs. § 1007-1-2.5

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Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1007-1-2.5 - Certification Evaluations
2.5.1 Frequency of Certification Evaluations.
2.5.1.1 Each radiation machine registrant shall have its radiation machine(s) and facility evaluated by a Department-approved qualified inspector annually, except as provided in 2.5.1.2 through 2.5.1.5.
(1) Each certification evaluation shall determine if the machine is safe for each intended use and is in compliance with the specifications of the equipment manufacturer and these regulations.
(2) Each certification evaluation subsequent to the initial certification evaluation shall be completed in or prior to the same calendar month as the previous certification evaluation.
(3) The calendar month of a certification evaluation of a machine in any month prior to the month in which it is due shall become the calendar month in which the subsequent certification is due.
(4) A certification evaluation conducted after the month in which it was due shall not change the month in which subsequent certification evaluations are due.
2.5.1.2 Each non-healing-arts x-ray imaging machine or system regulated by Parts 5, 8 or 9 shall be inspected at least every two (2) years. These include, but are not limited to, x-ray machines used for industrial radiography, nondestructive analysis, forensics or non-human security screening, foodstuff, packaging or equipment inspections or measurements.
2.5.1.3 Each bone densitometry, dental, podiatry or veterinary radiation machine shall be inspected at least every three (3) years, except that:
(1) Each radiographic x-ray machine used in non-intraoral dentistry or podiatry that is capable of continuously variable kilovoltage peak (kVp) or continuously variable milliamperage (mA) or continuously variable collimation shall be inspected annually.
(2) Each machine used in podiatry that is capable of operating at more than 30 mA shall be inspected annually.
(3) Each volumetric dental imaging system or computed tomographic system for human use shall be inspected annually.
(4) Each portable hand-held instrument used for any purpose on living humans shall be inspected annually.

TABLE 2-1: SUMMARY OF FREQUENCY OF RADIATION MACHINE CERTIFICATION EVALUATIONS

Category

Frequency of certification evaluation

Excluding systems used in veterinary medicine, and unless otherwise specified in this Table 2-1, each:

* General use x-ray system;

* CT (Computed Tomography) system;

* Fluoroscopy system;

* Dental Cone Beam Computed Tomography (CBCT) system;

* Volumetric dental imaging system;

* Hand-held x-ray imaging systems for human use;

* Podiatry system used at more than 30 mA;

* Non-intraoral dentistry or podiatry x-ray system capable of continuously variable kilovoltage peak (kVp) or continuously variable milliamperage (mA) or continuously variable collimation;

* Therapy systems for human or veterinary use;

* Security scanner x-ray systems used on living humans;

* All systems identified above entering the state under reciprocity for more than 180 days.

Every one (1) year

Each industrial (non-healing-arts) x-ray imaging machine or system regulated under Parts 5, 8 or 9 including:

* Security scanners for non-living human use;

* X-ray fluorescence (XRF) systems;

* Industrial radiography/Non-destructive testing;

* Forensics;

* Tissue specimen imaging systems;

* Scanning systems for food production or packaging inspection.

* Therapy systems for non-healing arts use.

Every two (2) years

Except as otherwise specified in this Table 2-1, each:

* Bone densitometry (DXA) system;

* Dental system;

* Podiatry system used at less than or equal to 30 mA;

* Veterinary system, including hand-held units.

Every three (3) years

2.5.1.4 Except as otherwise specified in regulation, each radiation machine shall have a certification evaluation performed within ninety (90) calendar days of:
(1) The initial installation of a new radiation machine, a radiation machine that is new to the facility, or a radiation machine that is relocated to a new area or room of an existing facility; or
(2) Any service after initial installation that could potentially affect radiation output (dose indices) or technique settings, including but not limited to the repair or replacement of high voltage generators, tube heads, consoles or image receptor systems.
(3) Receipt of a new radiation machine that does not require a physical installation, including hand-held x-ray systems, or portable or fixed x-ray systems that are battery operated or that plug into an electrical outlet.
2.5.1.5 The following radiation machines shall have a certification evaluation performed within ninety (90) calendar days of installation and prior to being used to perform any examination on living humans:
(1) Each initial (new) installation of a mammography imaging system. The evaluation must be performed by a registered medical physicist authorized in mammography;
(2) Each initial (new) installation of a Computed Tomography (CT) system, excluding volumetric dental imaging systems, dental CBCT systems, and digital breast tomosynthesis systems. The evaluation must be performed by or under the personal supervision of a registered medical physicist authorized in CT.
2.5.1.6 Any radiation machine and/or facility not inspected in accordance with 2.5.1.1 through 2.5.1.5, or otherwise determined to be out of compliance with these regulations, shall be subject to a Department enforcement inspection and subject to the fees specified in Part 12.
2.5.2 Procedures for Certification Evaluations by Qualified Inspectors.
2.5.2.1 Each qualified inspector who performs a certification evaluation of a radiation machine and facility evaluation shall use procedures that are sufficient to determine compliance with these regulations.
2.5.2.2 If a radiation machine fails to meet any requirement specified by these regulations, including manufacturer's required specifications, the qualified inspector shall notify the owner (registrant) or operator immediately and shall notify the department within three days after the determination.
2.5.2.3 If the radiation machine is determined to be unsafe (as provided in Part 6 and described in Appendix 6D), the qualified inspector shall affix to such radiation machine system, in a location clearly visible to the operator and patient, if applicable, an "Unsafe for Use" label authorized and issued by the Department, indicating, as applicable, that such machine is not authorized for human, animal or other use.
2.5.2.4 Reporting and Labeling Procedures.
(1) Each qualified inspector shall provide an accurate and complete Certification Evaluation Report to the registrant and to the Department on Form R 59-1, "X ray Machine Certification Evaluation Report," in accordance with the instructions contained in that form.
(a) A clear and legible report may be substituted for Form R 59-1, provided that it is in the same format and provides all of the information required by Form R 59-1.
(b) Violations of the regulations not related to the performance of the specific radiation machine(s) shall be reported to the registrant and Department using Form R 59-2, "X-ray Facility Compliance Evaluation Report," in accordance with the instructions contained in that form.
(c) Report(s) required by 2.5.2.4(1) shall indicate full or partial compliance and any specific violation of these regulations.
(d) Report(s) required by 2.5.2.4(1) shall include recommendations for corrective actions by the registrant (if applicable) to assist in achieving full compliance or improving radiation safety and the quality of the imaging process.
(e) The Department shall be notified within three (3) business days of radiation machine violations. Report(s) required by 2.5.2.4(1) that does not indicate violations shall be received by the Department no later than fifteen (15) calendar days after the inspection date, unless otherwise authorized by the Department.
(2) A certification label issued by the Department shall be affixed in a location clearly visible to the machine operator and patient, if applicable, when it is determined that the machine requirements of these regulations are fully met.
(a) For a machine that was found to be in full compliance, the certification label shall be affixed no later than fifteen (15) calendar days (unless otherwise authorized by the Department) after the inspection date.
(b) For a noncompliant machine, the certification label shall be affixed no later than fifteen (15) calendar days (unless otherwise authorized by the Department) after the date that full compliance was achieved.
(3) Each qualified inspector shall ensure that the following documentation is provided to the Department to confirm that each violation was corrected as required by 2.6.3.1 and/or 2.6.4.1 within thirty (30) calendar days of the date of inspection.
(a) For a noncompliant machine for which full compliance has been achieved, the completed documentation (on Form R 59-1 or equivalent) shall be received by the Department no later than fifteen (15) calendar days after the date that compliance was achieved.
(b) For a noncompliant facility, the completed documentation (on Form R 59-2 or equivalent) shall be received by the Department no later than fifteen (15) calendar days after the date that full compliance was achieved.
(4) Concealing, defacing or altering of Department-issued certification labels is prohibited.
(5) Repeated failure by a qualified inspector, to affix certification labels or to complete certification evaluation reports in a timely manner as provided in 2.5.2.4 shall be subject to review and audit as provided in 2.9 and also subject to the non routine inspection fee as provided in Part 12.

6 CCR 1007-1-2.5

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
47 CR 06, March 25, 2024, effective 4/14/2024