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http://dx.doi.org/10.17946/JRST.2015.38.4.01

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  

Roh, Young Hoon (Department of Nuclear Engineering & Radiologic Science School of Health and Environmental Science College of Health Science Korea University)
Kim, Jung Min (Department of Nuclear Engineering & Radiologic Science School of Health and Environmental Science College of Health Science Korea University)
Publication Information
Journal of radiological science and technology / v.38, no.4, 2015 , pp. 331-336 More about this Journal
Abstract
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.
Keywords
IEC publications; IEC 60601-1; IEC 60601-2-54 X-ray equipment for radiography or radioscopy; Particular requirements;
Citations & Related Records
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  • Reference
1 IEC 60601-1 : Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 2005
2 IEC 60601-1-3 : Medical electrical equipment - Part 1-3: General requirement for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment, 2008
3 IEC 60601-2-54 : Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy, 2009
4 JIS Z 4751-2-54 : Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy, 2012
5 Ministry of Food and Drugs Safety notification 2014-81(2014. 2. 12 revision), Standard of medical device 8. diagnostic X-ray equipment