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Oregon State University

7. Regulations Concerning Radiation Machines

7.1. Policy

Radiation-emitting machines must comply with specific registration and safety requirements in Chapter 333, Oregon Administrative Rules, and be acquired, used, stored, transferred, and disposed in accordance with accepted safety procedures.

7.2. Definitions

7.2.1.    Analytical x-ray machine: Any radiation machine that produces x-rays for the purpose of analyzing substances via x-ray diffraction or fluorescence.
7.2.2.    Cabinet radiography: Industrial radiography conducted in an enclosure or cabinet so shielded that every location on the exterior meets the dose limits for individual members of the public as specified in OAR 333-120-0180.
7.2.3.    Cabinet x-ray system: Any radiation machine constructed so that the useful beam is entirely within a shielded enclosure from which humans are excluded during use and into which items are placed for radiography or irradiation, but excluding healing arts machines and analytical x-ray machines. The enclosure must be interlocked so that x-rays will not be produced unless all openings are securely closed.
7.2.4.    Certifiable cabinet x-ray system - an existing uncertified x-ray system that has been modified to meet the certification requirements specified in 21 CFR 1020.40.
7.2.5.    Certified cabinet x-ray system: An x-ray system that has been certified in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of 21 CFR 1020.40.
7.2.6.    Failsafe: Design feature that results in termination of radiation emission in event of failure of the safety or warning device. Failsafe device requires a manual reset after device failure before emission of radiation can continue.
7.2.7.    Healing Arts Radiation Machine: Any radiation machine used to apply radiation to humans or animals for diagnosis or treatment of disease or malady by a licensed or registered practitioner of a Healing Art (medicine, dentistry, veterinary medicine, etc.).
7.2.8.    Other Radiation Machines - all other radiation machines that are not exempt from State of Oregon registration regulations. Generally, this includes: all particle accelerators, and  those electron microscopes, electron beam welders producing ionizing radiation only incidental to their furnaces, high voltage power supplies, and other devices that during operation emit radiation intensities exceeding 0.5 mrem/hr at 5 cm from any accessible surface, averaged over 10 cm2 area.

7.2.9.    Radiation Machine: Any device capable of producing ionizing radiation when the associated control devices are operated, but excluding devices that produce ionizing radiation only by the use of radioactive material.

7.3. Acquisition, Transfer, Disposal

7.3.1. Acquisition of a radiation machine, regardless of by purchase, gift, loan or other means, requires prior authorization by the Radiation Safety Committee that is specific for the machine to be acquired.
7.3.2. Acquisition documents (purchase requisition, etc.) should be approved by Radiation Safety (RS) to signify the acquisition complies with University regulations.
7.3.3. Transfer of possession to another Program Director within OSU requires following the procedure given in Section 4.
7.3.4. Transfer to a non-OSU entity or OSU surplus requires prior approval of RS signifying that the machine meets applicable regulatory requirements for legal transfer and insuring that the transaction will be properly reported per State regulations.
7.3.5. Disposal via disassembly or destruction requires prior approval of RS to ensure compliance with applicable regulations.
7.3.6. Deactivation and storage of a radiation machine requires that the machine be properly labeled and secured by RS to prevent operation without permission of that Office.

7.4. Use of Radiation Machines

7.4.1. General Regulations Applying to All Radiation Machines Each radiation machine shall be registered with the Oregon Health Authority prior to being put into use. Registration will be arranged by RS. Each radiation machine shall be inspected by RS after acquisition, relocation, modification, or repair. The machine shall not be put into use until found to comply with all applicable state and university regulations. The Program Director is responsible for notifying RS of completion of any of the above activities and arranging for the survey. Each approved operator and each person working with or near a radiation machine shall be given radiation safety training commensurate with the degree of hazard involved. Training shall be given by or for RS; documentation shall be maintained by RS. Refresher training shall be as specified by the Radiation Safety Committee. Each radiation machine shall be adequately secured against unauthorized use or relocation. Normally, this requires keeping room doors locked whenever the machine is unattended plus providing a key-locking device for the main power supply, with adequate key control. For each radiation machine, a machine log shall be maintained that contains: record of all maintenance activities, record of all radiation surveys and other safety-related tests, record for each time radiation is produced showing:

a. when the machine was operated and for how long,
b. the operator and any other persons possibly exposed,
c. machine configuration and operating parameters,
d. any failures or improper functioning of the machine plus determination of cause and any corrective or preventive actions taken. Each machine shall have posted nearby: Written instructions for normal operation, and for beam alignment if applicable, emergency instructions, copy of the Radiation Use Authorization, copy of Oregon "Notice to Employees" form or its successor, State annual registration certificate. Modification or relocation of a machine or associated other devices not specifically permitted by the RUA requires an amendment to the RUA. Machine operation shall never be deliberately terminated by activating a safety interlock except for test purposes. Radiation machines shall never be operated unless all specified shielding and other safety devices are in place and functioning properly, except when operated by a qualified repair person. Each radiation machine control panel shall be clearly labeled to caution individuals that the machine produces ionizing radiation when operated. Each radiation machine shall have a light clearly visible by the operator at the control switch that indicates whether radiation is or is not being produced. The indicator shall be fail-safe. RS personnel shall inspect each radiation machine after repair, after relocation, whenever abnormal readings of dosimeters indicate possible increase in radiation levels, and at sufficient other times to ensure that each machine is inspected at least once every two years.

7.4.2. Additional Regulations Pertaining to Cabinet Machines

Regulations listed in 7.4.1 apply to cabinet machines. Additional precautions needed for an individual machine will be listed in the RUA.

7.4.3. Additional Regulations Pertaining to Healing Arts Machines Regulations listed in sections 7.1, 7.2, 7.3 apply to Healing Arts machines. Additional precautions not given below will be listed on the RUA. Applicable provisions of 333-106 ORCR, "X-Rays in the Healing Arts" or its successor, shall be strictly adhered to. A copy of the applicable regulations shall be available at or near each machine.

7.4.4. Additional Regulations Pertaining to Analytical X-Ray Machines Regulations listed in 7.4.1 apply to Analytical X-Ray Machines. Additional precautions not given below will be listed on the RUA. Applicable provisions of 333-108, ORCR, "Radiation Safety Requirements for Analytical X-Ray Equipment" shall be strictly adhered to. A copy of the applicable regulations shall be available at or near each machine. Unless specified otherwise in the RUA, each analytical machine shall be surveyed by its operator or RS each time a camera, beam stop, or other similar device is removed or relocated from its position, whether replaced or not, before beginning alignment, at appropriate times during alignment, and immediately upon completion of alignment, and at any other times that abnormal radiation conditions are suspected or known. Each such survey shall be properly documented, and a report retained and kept available near the machine. Dosimeter requirements will be specified in the RUA. Each usable port shall be fitted with a safety shutter of fail-safe design. This shutter shall include a "shutter open" light or other prominent status indicator near the port. Each unused port shall be secured by some means requiring tools to open. Inadvertent access to any primary beam during operation shall be prevented by an approved enclosure interlocked to keep the shutter closed or to prevent x-ray production whenever the enclosure is not closed during x-ray production. Manual reset of the shutter or power supply after interlock trip is mandatory. Enclosure shall include sufficient shielding to reduce the radiation level at any accessible point outside the enclosure to no more than 2 mrem/hr. Circuitry must provide for operation with enclosure open by approved operators during sample alignment and by approved repair persons during repair and maintenance. Each machine shall be located and oriented to minimize radiation exposure potential to persons in the area. Operation of the machine with any of the safety interlocks bypassed requires the prior written approval of the RSO.

7.4.5. Additional Regulations for Other Radiation Machines All machines not fitting into the three categories listed in Sections 7.4.2, 7.4.3 and 7.4.4 shall have any additional specific precautions listed in the RUA. The precautions shall be comparable to those listed above but modified to fit the particular situations.