6 CCR 1007-1
DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT RADIATION CONTROL - RADIATION SAFETY REQUIREMENTS FOR RADIATION GENERATING DEVICES NOT USED IN THE HEALING ARTS 6 CCR 1007-1 Part 08 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ PART 8: RADIATION SAFETY REQUIREMENTS FOR RADIATION GENERATING DEVICES NOT USED IN THE HEALING ARTS
8.1 Purpose and Scope.
8.1.1 Authority.
8.1.1.1 Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25-1-108, 25-1.5-101(1)(l), and 25-11-104, CRS.
8.1.2 Basis and Purpose.
8.1.2.1 A statement of basis and purpose accompanies this part and changes to this part. A copy may be obtained from the Department.
8.1.3 Scope.
8.1.3.1 This part provides special requirements for non-healing-arts radiation generating devices, such as analytical equipment used for x-ray diffraction or fluorescence analysis.
8.1.4 Applicability.
8.1.4.1 The requirements and provisions of these regulations apply to applicants, licensees and registrants within the scope of by Part 8 unless specifically exempted by Part 8.
8.1.4.2 The applicable special requirements of Part 5 also apply if an image receptor is used to transform incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformation.
8.1.4.3 The requirements of by Part 8 are in addition to, and not in substitution for, applicable requirements in other parts of these regulations.
8.1.5 Published Material Incorporated by Reference.
8.1.5.1 Published material incorporated in Part 8 by reference is available in accord with Part 1, Section 1.4.
8.2 Definitions.
8.2.1 Definitions of general applicability to these regulations are in Part 1, section 1.2.
8.2.2 As used in Part 8, each term below has the definition set forth.
“Analytical x-ray system” means a group of components utilizing x-rays or gamma rays to determine the elemental composition, examine the microstructure, and/or ascertain characteristics of materials.
“Fail-safe characteristic” means a design feature that causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of a safety or warning device.
“Local component” means a part of an analytical x-ray system in an area that is struck by x-rays, such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, not including power supplies, transformers, amplifiers, readout devices, and control panels.
“Normal operating procedures” means a set of step-by-step instructions necessary to accomplish the analysis.
“Open-beam configuration” means an analytical x-ray system in which an individual could accidentally place some part of the body in the primary beam path during normal operation. “Primary beam” means ionizing radiation which passes through an aperture of the source housing by a direct path from the x-ray tube or a radioactive source located in the radiation source housing.
General Regulatory Provisions and Specific Requirements
8.3 Administrative Requirements.
8.3.1 Each non-healing-arts radiation machine in the State of Colorado shall be registered with the Department as required by 2.4 and inspected as prescribed in 2.5.
8.3.2 The registrant shall direct operation of the x-ray equipment under the registrant’s administrative control.
8.3.3 The registrant or the registrant's agent shall assure that all applicable requirements of Parts 1, 2, 4, 5, 6 and 10 are met in the operation of the x-ray equipment.
8.3.4 As provided in 2.6.1.15, for any analytical, industrial or other non-healing-arts radiation machine, “adequately trained” shall mean that the individual operator has met the requirements of Part 2, Appendix 2N.
8.4 Equipment Requirements.
8.4.1 Safety Device.
8.4.1.1 A device which prevents the entry of any portion of an individual's body into the primary x-ray beam path, or which causes the beam to be shut off upon entry into its path, shall be provided on all open-beam configurations.
8.4.1.2 A registrant or licensee may apply to the Department for an exemption from the requirement of a safety device, including in the application:
(1) A description of the various safety devices that have been evaluated;
(2) The reason each of these devices cannot be used; and (3) A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area will be informed of the absence of safety devices.
8.4.2 Warning Devices.
8.4.2.1 Open-beam configurations shall be provided with a readily discernible indication of:
(1) X-ray tube “on-off” status located near the radiation source housing, if the primary beam is controlled in this manner; and/or (2) Shutter “open-closed” status located near each port on the radiation source housing, if the primary beam is controlled in this manner.
8.4.2.2 An easily visible warning light labeled with the words “X-RAY ON”, or words having a similar intent, shall be located:
(1) Near any switch that energizes an x-ray tube and shall be illuminated only when the tube is energized; or (2) In the case of a radioactive source, near any switch that opens a housing shutter and shall be illuminated only when the shutter is open.
8.4.2.3 Warning devices shall be labeled so that their purpose is easily identified.
(1) Warning devices shall have fail-safe characteristics.
8.4.3 Ports.
8.4.3.1 Unused ports on radiation source housings shall be secured in the closed position, in a manner that will prevent casual opening.
8.4.4 Labeling.
8.4.4.1 All analytical x-ray equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:
(1) “CAUTION - HIGH INTENSITY X-RAY BEAM”, or words having a similar intent, on the x-ray source housing; and (2) “CAUTION - RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED”, or words having a similar intent, near any switch that energizes an x-ray tube if the radiation source is an x-ray tube; or (3) “CAUTION - RADIOACTIVE MATERIAL”, or words having a similar intent, on the source housing in accordance with 4.30 of these regulations if the radiation source is a radionuclide.
8.4.5 Shutters.
8.4.5.1 On open-beam configurations, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
8.4.6 Radiation Source Housing.
8.4.6.1 Each radiation source housing shall be subject to the following requirements:
(1) Each x-ray tube housing shall be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing, or if the housing is disassembled.
(2) Each radioactive source housing, or port cover or each x-ray tube housing shall be so constructed that, with all shutters closed, the radiation measured at a distance of 5 centimeters from its surface is not capable of producing a dose in excess of 0.025 mSv (2.5 millirem) in one hour.
8.4.7 Generator Cabinet.
8.4.7.1 Each x-ray generator shall be supplied with a protective cabinet that limits leakage radiation measured at a distance of 5 centimeters from its surface such that it is not capable of producing a dose in excess of 2.5 µSv (0.25 millirem) in one hour.
8.5 Operating Requirements.
8.5.1 Procedures.
8.5.1.1 Normal operating procedures shall be written and available to all analytical x-ray equipment workers.
8.5.1.2 The written operating procedures shall include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant, emergencies such as a power failure, and data recording procedures which are related to radiation safety.
8.5.1.3 No individual shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such individual has obtained written approval of the radiation safety officer and Department.
8.5.2 Bypassing.
8.5.2.1 No individual shall bypass a safety device or interlock, unless such individual has obtained the written approval of the radiation safety officer and Department.
(1) 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.
8.5.3 Repair or Modification of X-ray Tube Systems.
8.5.3.1 Except as specified in 8.5.2, 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.
8.5.3.2 The main switch, rather than interlocks, shall be used for routine shutdown in preparation for repairs.
8.5.4 Radioactive Source Replacement, Testing, or Repair.
8.5.4.1 Radioactive source housings shall be opened for source replacement, leak testing, or other maintenance or repair procedures only by individuals authorized to specifically conduct such procedures under a license issued by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.
8.5.4.2 The registrant or the registrant's agent shall use licensed/certified/registered providers of services, including but not limited to operation of equipment, inspection of radiation machines and facilities, and assembly, installation, service and/or calibration of radiation machines.
8.5.5 Posting.
8.5.5.1 Each area or room containing analytical x-ray equipment shall be conspicuously posted with a sign, or signs bearing the radiation symbol and the words “CAUTION - X-RAY EQUIPMENT” or words having a similar intent in accordance with 4.28 of these regulations.
8.5.6 Hand-held Devices.
8.5.6.1 The operator shall be protected from direct scatter radiation by material of not less than 0.25 millimeter lead equivalent unless the radiation safety officer and Department determine that no added protection is needed for the device use and/or model.
8.6 Measurements, Monitoring and Surveys.
8.6.1 Radiation Levels.
8.6.1.1 X-ray equipment shall be located and arranged with sufficient shielding and area access control to ensure compliance with Part 4.
8.6.1.2 The registrant shall assure that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits in 4.14 or 4.15.
8.6.2 The registrant shall possess (unless determined by the radiation safety officer and Department to be unnecessary) at least one portable radiation detection survey instrument that is:
8.6.2.1 Capable of detecting dose rates over the range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour;
8.6.2.2 Operable; and
8.6.2.3 Calibrated in accordance with 2.4.4.4.
8.6.3 Surveys.
8.6.3.1 The registrant shall document performance of radiation surveys, as required by 4.17 of these regulations, sufficient to show compliance with 8.6.1:
(1) Upon installation of the equipment, and at least once every 12 months thereafter;
(2) Following any change in the geometrical arrangement, number, or type of local components in the system;
(3) Following any maintenance requiring disassembly, or removal of a local component in the system;
(4) During the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled, or removed;
(5) Any time a visual inspection of the local components in the system reveals an abnormal condition; and (6) Whenever personnel monitoring devices show a significant increase over the previous monitoring period, or the readings are approaching the limits specified in 4.6 of these regulations.
8.6.4 Personnel Monitoring Requirements.
8.6.4.1 Each individual who is associated with the operation of an non-healing-arts radiation generating device shall meet the requirements of 4.6, 4.10, 4.12, 4.13, 4.14, and 4.18.
(1) When personnel dosimetric monitoring devices are required, they shall be worn in accordance with 4.6.3.
(2) Each operator of portable hand-held x-ray equipment shall wear whole body and extremity personnel dosimetric monitoring devices.
(3) Deliberate exposure of a personnel dosimetric monitoring device to deceptively indicate a dose delivered to an individual is strictly prohibited.
8.6.4.2 Finger or wrist dosimetric devices shall be provided to and shall be used by:
(1) Analytical x-ray equipment operators using systems having an open-beam configuration if and when a safety device is not present, is not in use or is disabled; and (2) Personnel maintaining analytical x-ray equipment if the maintenance procedures require the presence of a primary x-ray beam when any local component in the analytical x-ray system is disassembled or removed.
8.6.4.3 Reported dose values shall not be used for the purpose of determining compliance with
4.6 unless evaluated by a qualified expert.
8.7 Quality Assurance Requirements.
8.7.1 Each non-healing arts radiation generating device shall have written quality control and quality assurance procedures that follow:
8.7.1.1 Specifications of the manufacturer; and
8.7.1.2 Specifications of the radiation safety officer; and/or
8.7.1.3 Standards of an appropriate nationally recognized organization.
_________________________________________________________________________ EDITOR’S NOTES 6 CCR 1007-1 has been divided into separate parts for ease of use. Versions prior to 04/01/2007 are located in the first section, 6 CCR 1007-1. Prior versions can be accessed from the All Versions list on the rule’s current version page. To view versions effective on or after 04/01/2007, select the desired part of the rule, for example 6 CCR 1007-1 Part 01 or 6 CCR 1007-1 Part 10. History Part 08 entire rule eff. 07/01/2010.