KMID : 0357520150380040331
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Journal of Radiological Science and Technology 2015 Volume.38 No. 4 p.331 ~ p.336
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The Tendency of Medical Electrical Equipment - IEC 60601-2-54: Particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy
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Roh Young-Hoon
Kim Jung-Min
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Abstract
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Medical electrical equipment - Part 1: General requirement for basic safety and essential performance of MFDS was revised as 3th edition and Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment will be expected to be announced as notification. Therefore this technical report was written to introduce provision of the particular requirements, replacement, addition, amendment. The purpose of this particular requirements is to secure requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy. X-ray high voltage generator, mechanical protective device, protection against radiation is included in this particular requirements. Medical electrical equipment - Part 1, Part 1-2, Part 1-3 is applied to this particular requirements. If the requirements is announced as notification, It is expected to widen understanding for basic safety and essential performance of X-ray equipment for radiography and radioscopy and play a part to internationalize of medical equipments.
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KEYWORD
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IEC publications, IEC 60601-1, IEC 60601-2-54 X-ray equipment for radiography or radioscopy, Particular requirements
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