6 Colo. Code Regs. § 1007-1-6.8

Current through Register Vol. 47, No. 11, June 10, 2024

Section 6 CCR 1007-1-6.8 - Requirements for use of a veterinary medicine imaging system

6.8.1 Administrative Controls.

6.8.1.1 In addition to the provisions of 6.3 and 6.4, the requirements of this 6.8, and as appropriate also 6.5 and 6.9, apply to equipment and associated facilities used for veterinary x-ray imaging.

6.8.1.2 Each individual who operates a veterinary x-ray imaging system shall meet the applicable adequate radiation safety training and experience requirements of Part 2, sections 2.6.1 and specifically 2.6.1.13.

6.8.2 Each veterinary medicine installation shall meet the following equipment design and configuration requirements.

6.8.2.1 Equipment.

(1) The protective tube housing shall be equivalent to the requirements of 6.4.2.3.

(2) Diaphragms or cones shall be provided for collimating the useful beam to the area of clinical interest and shall provide the same degree of protection as is required of the housing.

(3) The total filtration permanently in the useful beam shall meet the requirement of 6.4.2.5(1).

(4) All stationary, mobile or portable x-ray systems shall be provided with either:

(a) A lead-equivalent protective garment with thyroid shielding and lead-equivalent eye protection.

(b) A 2 meter (more than 6 feet) high protective barrier for operator protection during exposures; or

(c) Shall be provided with means to allow the operator to be at least 2 meters (more than 6 feet) from the patient, x-ray tube, and the useful beam during exposures.

6.8.2.2 A method shall be provided for visually defining the perimeter of the x-ray field.

(1) The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed 2 (two) percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.

6.8.2.3 Structural Shielding.

(1) All wall, ceiling, and floor areas shall be equivalent to or provided with applicable protective barriers to assure compliance with 4.6, 4.12, 4.13, and 4.14.

(2) A veterinary installation shall meet the requirements of 6.3.2 in order to minimize radiation exposure to personnel and individual members of the public.

(3) Veterinary facilities are exempt from the requirements of Appendix 6B so long as the requirements of 6.8.3 are met.

6.8.2.4 Linearity shall be in accord with 21 CFR 1020.31(c)(3).

6.8.2.5 Accuracy.

(1) Deviation of exposure settings from indicated values shall not exceed the limits specified for that system by its manufacturer.

(2) If manufacturer specifications are not available, the following criteria shall be used:

(a) The kVp shall not deviate from indicated values by more than ten (10) percent.

(b) The timer accuracy shall not deviate from indicated values by more than:

(i) Ten (10) percent for an indicated time of greater than 20 ms; or

(ii) Fifty (50) percent for an indicated time of 20 ms or less, or 1 pulse, whichever is greater.

6.8.2.6 Timers.

(1) Means shall be provided to terminate the exposure at a preset time interval, preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.

(2) It shall not be possible to make an exposure when the timer is set to a "zero" or "off" position if either position is provided.

(3) Termination of exposure shall cause automatic resetting of the timer to its initial setting or to "zero".

6.8.2.7 Exposure Reproducibility.

(1) The coefficient of variation of exposure shall not exceed 0.05 when all exposure settings are held constant.

6.8.2.8 A dead-man type of exposure switch or equivalent remote device shall enable the operator to stand out of the useful beam.

6.8.3 Each veterinary medicine installation shall have the following operating and radiation exposure control procedures.

6.8.3.1 Whenever possible, the operator shall be positioned during radiographic exposures so that the nearest portion of the body is at least 2 meters (more than 6 feet) from the patient, x-ray tube and the useful beam.

6.8.3.2 No individual, other than the operator, shall be in the x-ray room while exposures are being made, unless such individual's assistance is required and the person is adequately protected by shielding and/or distance.

(1) All other staff and ancillary personnel required for the procedure shall:

(a) Be protected from scatter radiation by protective apparel (aprons) or whole body protective barriers of not less than 0.25 millimeter lead equivalent; and

(b) Be protected from the useful beam by 0.5 millimeter lead equivalent.

6.8.3.3 When an animal must be held in position during radiography, mechanical supporting or restraining devices should be used.

(1) Each individual other than the animal being examined shall be positioned such that no part of the body will be struck by the useful beam unless protected by a minimum of 0.5 millimeter lead equivalent protective apparel or shield.

(2) If the animal must be held by an individual, that individual shall be protected with appropriate shielding devices, such as protective apparel (gloves and apron), and the individual shall be so positioned that no part of the individual's body will be struck by the useful beam.

(3) The exposure of any individual used for this purpose shall be maintained below the limits specified in 4.6, 4.12, and 4.13.

6.8.3.4 No human shall hold the image receptor during radiography unless that individual is protected with appropriate shielding devices or protective apparel (gloves and apron), and that any part of his/her body struck by the useful beam shall be monitored.

(1) The exposure of any individual used for this purpose shall be maintained below the limits specified in 4.6, 4.12, and 4.13.

6.8.3.5 Use of hand-held x-ray equipment shall be consistent with Appendix 6E.

6.8.4 Each veterinary x-ray imaging system shall follow manufacturer maintenance specifications.

6.8.5 Each veterinary x-ray imaging system shall have written quality control and quality assurance procedures that include:

6.8.5.1 For processing of veterinary films, performance of the following:

(1) Follow applicable manufacturer's time and temperature specifications, which shall be available for review;

(2) Measure and log temperature each day of use; and

(3) Document in a written log the change of developer chemicals at least every month.

6.8.5.2 Annual review of all quality control tests.

6 CCR 1007-1-6.8

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