6 Colo. Code Regs. § 1007-1-8.4

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

Section 6 CCR 1007-1-8.4 - General regulatory requirements

Unless otherwise provided in this Part, this Section 8.4 applies to all RGDs. Certified and Certifiable Cabinet X-ray Systems as defined in this Part shall also meet the requirements of 21 CFR 1020.40.

8.4.1 Warning Devices.

A. Warning devices shall be labeled so that their purpose is easily identified.

B. An easily visible warning light labeled with the words "X-RAY ON", or words/displays having a similar intent, shall be located near any switch or control system that energizes an x-ray tube and shall be illuminated only when the tube is energized. This warning light/display shall be of a fail-safe design.

8.4.2 Labeling.

A. All RGD equipment shall be labeled with a readily visible and discernible sign or signs bearing the radiation symbol (in accordance with Part 4, Section 4.27) and the words: "CAUTION - RADIATION- THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED", or words having a similar intent, near any switch that energizes an x-ray tube.

B. For RGDs with designed openings, for object entries (such as baggage units), the following shall be posted at or near each opening: "CAUTION- X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED", or words having similar intent.

8.4.3 Radiation Source Housing.

A. Each radiation source housing shall be subject to the following requirements:

1. Interlock.

When the x-ray tube housing is the primary shielding for the x-ray tube, and is intended to be opened for normal use or maintenance, the housing shall be equipped with an interlock that shuts off the high voltage to the x-ray tube if the housing is opened; and

2. Radiation emission limit.

Each x-ray tube housing shall be so constructed that, with all shutters closed, the radiation measured at a distance of 5 centimeters from the x-ray tube housing surface does not exceed 2.5 mrem (0.025 mSv) per hour This limit shall be met at the maximum tube rating.

a. For closed-beam RGDs, this requirement can be met by complying with 8.6.4, radiation emission limit (0.5 mrem or 0.005 mSv in one hour at five centimeters outside any accessible surface).

b. For a RGD in a shielded room, this limit can be met by measuring from any accessible surface outside the room housing the RGD.

c. For open-beam RGDs designed to be hand-held during operation, this requirement can be met by complying with the limits in 8.8.3, radiation emission limit (2.5 mrem or 0.025 mSv per hour at 5 centimeters.

8.4.4 Generator Cabinet or High Voltage Source Radiation Emission Limits

A. Each x-ray generator or high-voltage source associated with an RGD shall be supplied with a protective cabinet which limits leakage radiation to 0.25 mrem (2.5 µSv) per hour at a distance of 5 centimeters measured at the nearest accessible surface.

1. For closed beam systems, this requirement can be met by complying with Section 8.6.4, radiation emission limit (0.5 mrem or 0.005 mSv in one hour at five centimeters outside any accessible surface).

2. For a RGD in a shielded room with the high-voltage generator also inside the shielded room, this limit can be met by measuring from any accessible surface outside the room housing the RGD. 3. For hand-held, open-beam RGDs, this requirement can be met by complying with the limits in 8.8.3, radiation emission limit (2.5 mrem or 0.025 mSv per hour at 5 centimeters).

8.4.5 Surveys.

A. The registrant shall document performance of radiation surveys, as required by Part 4, Section 4.17 of these regulations and shall be sufficient to show compliance with radiation emission requirements of this Part, and as required by Part 4, Section 4.6 and Part 4, Section 4.14 of these regulations. The radiation surveys shall be sufficient to evaluate the magnitude and extent of radiation emissions and the potential radiological hazards that could be present.

At a minimum, surveys shall be performed:

1. Upon installation of the equipment, and at least once during each routine certification evaluation thereafter;

2. Following any change in the initial arrangement, number, or type of local components in the system;

3. Following any maintenance requiring the disassembly, removal, or repair of a local component in the system;

4. During the performance of maintenance, calibration and other procedures if the procedures require the activation of a primary x-ray beam while any local component in the system is disassembled or removed;

5. Following the temporary bypass and restoration of a safety device or interlock required by 8.4.7.B.

6. Any time a visual inspection of the local components in the system reveals an abnormal condition; and

7. Whenever a personnel monitoring device shows a significant increase over the previous monitoring period, or the readings are approaching the limits specified in 4.6 of these regulations.

B. The registrant shall have access to sufficiently calibrated, appropriate and operable radiation survey instruments to make physical radiation surveys as required by this Part. The instruments shall be capable of detecting and measuring the types and levels of radiation involved (including primary, scattered, and leakage radiation).

C. The registrant shall assure the maintenance and calibration of all monitoring and survey instruments per Part 4, Section 4.17 of the regulations.

D. Radiation survey measurements shall not be required if a registrant can otherwise demonstrate compliance with the requirements of this Part to the satisfaction of the Department.

8.4.6 Posting.

A. Each area or room containing an RGD where an individual may receive 2 mrem (0.02 mSv) in any one hour or 100 mrem (1 mSv) per year shall be conspicuously posted with a sign or signs bearing the radiation symbol (which meets the requirements of Part 4, Section 4.27) and the words "CAUTION - X-RAY EQUIPMENT," "CAUTION - RADIATION GENERATING DEVICE" or words having a similar intent.

B. Unless used in a dedicated location, hand-held RGDs are exempt from the requirements of 8.4.6.A.

8.4.7 Security.

A. When not in operation, RGDs shall be secured in such a way as to prevent access or operation by unauthorized personnel.

8.4.8 Operating Requirements.

A. Procedures.

1. Normal operating procedures shall be written and available to all RGD operators.

2. No individual shall be permitted to operate a RGD in any manner other than that specified in the procedures unless such individual has obtained written approval of the RSO and Department.

3. Except as authorized under Part 6 for authorized medical purposes, or Section 8.11 for security screening purposes, intentional exposure of a living human to a RGD for any purpose is strictly prohibited.

B. Bypassing safety equipment.

1. No individual shall bypass a safety device or interlock, unless such individual has obtained the written approval of the RSO and Department. Such approval shall be for a specified period of time.

2. When a safety device or interlock has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING", or words having a similar intent, shall be placed on the radiation source housing and at the control switch.

3. A record of any bypass of a safety device or interlock shall be maintained; the record shall contain such information as the date the alteration was made, type of alteration, length of time the unit remained in the altered condition, post bypass survey and signed by the RSO, the individual who made the alteration, and the individual who restored the unit to original condition.

4. Control panel.

a. The RGD can only be activated from a control panel.

b. All indicators and controls that control the primary beam shall be identifiable and discernible through the use of labels, symbols, software displays or the equivalent.

C. Interlocks.

1. An interlock shall not be used to de-activate the x-ray tube or RGD, except in an emergency or during testing of the interlock system.

2. After triggering any interlock, it shall be possible to reset the RGD to full operation only from a control panel.

3. All interlocks shall be of a fail-safe design.

4. When the system is in normal use, interlocks, including emergency shut off controls, shall not be defeated, or otherwise made inoperable or inaccessible such that the operability or primary purpose is impacted.

D. Multiple sources.

If more than one x-ray tube assembly(s) or focal spot can be operated sequentially or simultaneously from a control panel, visual indicators shall identify which tube assembly(s) or focal spot has been selected. The selectors shall be identified as to their function. If a letter or number is used, a reference card or table explaining the code shall be affixed to the control panel.

8.4.9. Repair or Modification of X-ray Tube or RGD Systems.

A. Only registered service companies shall be permitted to install, repair, calibrate, or make modifications to an RGD and only Qualified Inspectors shall perform machine inspections.

B. No operation involving removal of covers, shielding materials or tube housings or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the tube is off and will remain off until safe conditions have been restored.

C. The main power switch with a lock-out / tag-out, rather than interlocks, shall be used for routine shutdown in preparation for repairs.

8.4.10. Testing of Safety Devices.

A. Tests of all safety devices, such as interlocks, shutters, warning lights, and required emergency shut-off switches shall be conducted at intervals not to exceed 6 months on all operable RGDs. Cabinet integrity, where applicable, shall be evaluated at the same time and frequency as safety device tests.

B. If any safety device fails during testing, the RGD shall be removed from service until the safety device failure is corrected or proper temporary administrative controls established and approved in writing by the RSO.

C. Records of safety device tests, check dates, findings and corrective actions shall be available for inspection and maintained for 3 years.

D. Records shall include the date of the test, a list of the safety devices tested, survey instrument information, calibration date, the results of the test, the name of the person performing the tests and corrective actions taken for safety devices that fail the required test.

E. Testing of safety devices may be deferred if the unit and/or installation is clearly marked and kept out of service; units and/or installations brought back into service after exceeding the 6 month interval shall be tested prior to use.

F. If testing of a safety device cannot be performed due to manufacturer design, the registrant shall document that the safety device will not be tested and specifically why the safety device cannot be tested.

8.4.11 Instruction and Training.

The registrant shall document the scope of training required for the RGD they possess in accordance with this section. No individual shall be permitted to operate or maintain an RGD, or enter a shielded room without appropriate instruction and training. Records of all required training and instruction shall be maintained onsite for a minimum of 3 years after the individual terminates employment. Records shall be made available for review by the Department.

Each individual shall receive instruction in and demonstrated competence as to:

A. Types of radiation and identification of radiation hazards associated with the use of the RGD and associated equipment and precautions or measures to take to minimize radiation exposure;

B. Significance of the various radiation warning, safety devices, and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;

C. Commensurate with potential hazards of use, biological effects of radiation, radiation risks, and recognition of symptoms of an acute localized exposure;

D. Normal operating procedures for each type of RGD and associated equipment, including having received hands-on training, and procedures to prevent unauthorized use;

E. Procedures for reporting an actual or suspected accidental exposure or other radiation safety concerns, such as any unusual occurrence or malfunction that may involve exposure to radiation; and

F. Performing surveys where applicable.

8.4.12. Radiation Protection Responsibility.

A. The registrant's senior management shall make the ultimate decision to use any RGD and ultimately be responsible for radiation safety.

B. The registrant's senior management shall designate an individual responsible for radiation safety, or a RSO. This individual shall have direct access to senior management for radiation safety issues. This individual shall have training and experience commensurate with the scope of the radiation safety program to carry out the responsibilities as indicated below.

1. Ensuring that all RGDs are operated within the limitations of the established radiation safety program and operating procedures.

2. Instructing personnel with regard to safe working practices and ensuring all personnel are trained in radiation safety commensurate with the hazards of the job.

3. Investigating any incident of abnormal operation or exposure or suspected overexposure of personnel to determine the cause, take remedial action, and report the incident to the proper authority.

4. Ensuring that safety devices, interlocks, warning signals, labels, postings, and signs are functioning and located where required.

5. Maintain all radiation safety records.

6 CCR 1007-1-8.4

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