sioning use maintenance and quality control of such material should be

Sioning use maintenance and quality control of such

This preview shows page 601 - 603 out of 696 pages.

sioning, use, maintenance and quality control of such material should be developed with the involvement of qualified experts and the quality assurance/ radiation protection committee. Paragraph II.13 of the BSS (Appendix II, Medical Exposure, Optimi- zation of Protection for Medical Exposures) states, inter alia, that: Registrants and licensees, in specific co-operation with suppliers, shall ensure that, with regard to equipment consisting of radiation generators and that containing sealed sources used for medical exposures: (a) whether imported into or manufactured in the country where it is used, the equipment conform to applicable standards of the International Electrotechnical Commission (IEC) and the ISO or to equivalent national standards; (b) performance specifications and operating and maintenance instructions, including protection and safety instructions, be provided in a major world language understandable to the users and in compliance with the relevant IEC or ISO standards with regard to ‘accompanying documents’, and that this information be translated into local languages when appropriate; (c) where practicable, the operating terminology (or its abbreviations) and operating values be displayed on operating consoles in a major world language acceptable to the user;… Paragraph II.15 of the BSS (Appendix II, Medical Exposure, Optimi- zation of Protection for Medical Exposures) states, inter alia, that: Registrants and licensees, in specific co-operation with suppliers, shall ensure that:
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CHAPTER 16 564 (a) radiation installations using radioactive sources be fail-safe in the sense that the source will be automatically shielded in the event of an interruption of power and will remain shielded until the beam control mechanism is reactivated from the control panel; (b) high energy radiotherapy equipment should: (i) have at least two independent ‘fail to safety’ systems for terminating the irradiation; and (ii) be provided with safety interlocks or other means designed to prevent the clinical use of the machine in conditions other than those selected at the control panel;… The IEC standards applicable to radiotherapy are: IEC 601-2-1, for medical electron accelerators; IEC 60601-2-11, for external beam radiotherapy; IEC 60601-2-17, for remote afterloading brachytherapy; IEC 601-2-8, for superficial therapy with X rays; IEC 60601-2-29, for therapy simulators; IEC 62C/62083, for treatment planning systems (TPSs); IEC 60601-1-4, for computer controlled or programmable medical systems. Evidence of compliance with the IEC or equivalent national standards should be demonstrated. For type tests, sufficient evidence of compliance may be provided by the manufacturer’s records with the results of the tests for the relevant equipment type and model. This should be supplemented by acceptance tests for the individual piece of equipment delivered. The relevant safety tests described in the IEC standards should be included in the acceptance protocol and be specified in the purchasing conditions. More detailed guidance is provided in IAEA-TECDOC-1040.
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