R313-35-100. Analytical X-Ray Systems Excluding Cabinet X-Ray Systems

(1) Equipment. Analytical x-ray systems not contained in cabinet x-ray systems shall meet all the following requirements.

(a) A device which prevents the entry of portions 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 for open-beam configurations.

(i) Pursuant to R313-12-55(1), an application for an exemption from R313-35-100(1)(a) shall contain the following information:

(A) a description of the various safety devices that have been evaluated;

(B) the reason that these devices cannot be used; and

(C) 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.

(ii) applications for exemptions to R313-35-100(1)(a) shall be submitted to the Director.

(b) Open-beam configurations shall be provided with a readily discernible indication of:

(i) the "on" or "off" status of the x-ray tube which shall be located near the radiation source housing if the primary beam is controlled in this manner; or

(ii) the "open" or "closed" status of the shutters which shall be located near ports on the radiation source housing, if the primary beam is controlled in this manner.

(c) Warning devices shall be labeled so that their purpose is easily identified and the devices shall be conspicuous at the beam port. On equipment installed after July 1, 1989, warning devices shall have fail-safe characteristics.

(d) Unused ports on radiation source housings shall be secured in the closed position in a manner which will prevent casual opening. Security requirements will be deemed met if the beam port cannot be opened without the use of tools that are not part of the closure.

(e) Analytical x-ray systems shall be labeled with a readily discernable sign or signs bearing a radiation symbol which meets the requirements of R313-15-901 and the words:

(i) "CAUTION-HIGH INTENSITY X-RAY BEAM," or words having a similar intent, on the x-ray tube housing; and

(ii) "CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED," or words having a similar intent, near switches that energize an x-ray tube.

(f) On analytical x-ray systems with open-beam configurations which are installed after July 1, 1989, ports 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.

(g) An easily visible warning light labeled with the words "X-RAY ON," or words having a similar intent, shall be located near switches that energize an x-ray tube and near x-ray ports. They shall be illuminated only when the tube is energized.

(h) On analytical x-ray systems installed after July 1, 1989, warning lights shall have fail-safe characteristics.

(i) X-ray generators shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of five centimeters from its surface so that they are not capable of producing a dose equivalent in excess of 2.5 microsieverts (0.25 millirem) in one hour.

(j) The components of an analytical x-ray system located in an uncontrolled area shall be arranged and include sufficient shielding or access control so that no radiation levels exist in areas surrounding the component group which could result in a dose to an individual present therein in excess of the dose limits given in R313-15-301.

(2) Personnel Requirements.

(a) An individual shall not be permitted to operate or maintain an analytical x-ray system unless the individual has received instruction which satisfies the requirements of R313-18-12(1). The instruction shall include:

(i) identification of radiation hazards associated with the use of the analytical x-ray system;

(ii) the significance of the various radiation warnings and safety devices incorporated into the analytical x-ray system, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in these cases;

(iii) proper operating procedures for the analytical x-ray system;

(iv) symptoms of an acute localized exposure; and

(v) proper procedures for reporting an actual or suspected exposure.

(b) Registrants shall maintain records which demonstrate compliance with the requirements of R313-35-100(2)(a) for a period of three years after the termination of the individual.

(c) Normal operating procedures shall be written and available to analytical x-ray system workers. An individual shall not be permitted to operate analytical x-ray systems using procedures other than those specified in the normal operating procedures unless the individual has obtained written approval of the registrant or the registrant's designee.

(d) An individual shall not bypass a safety device unless the individual has obtained the written approval of the registrant or the registrant's designee. Approval shall be for a specified period of time. When a safety device 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.

(3) Personnel Monitoring. In addition to the requirements of R313-15-502, finger or wrist dosimetric devices shall be provided to and shall be used by:

(a) analytical x-ray system workers using equipment having an open-beam configuration and not equipped with a safety device; and

(b) personnel maintaining analytical x-ray systems if the maintenance procedures require the presence of a primary x-ray beam when local components in the analytical x-ray system are disassembled or removed.

(4) Posting. Areas or rooms containing analytical x-ray systems not considered to be cabinet x-ray systems shall be conspicuously posted to satisfy the requirements in R313-15-902.