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    IEC 60601-2-54:2009+AMD1:2015+AMD2:2018 CSV

    Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
    • 발행일 : 2018-06-29
    • 발행기관 : IEC
    • 대체표준 : IEC 60601-2-54:2022
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분야 TC 62/SC 62B : Medical imaging equipment, software, and systems
적용범위 IEC 60601-2-54:2009+A1:2015+A2:2018 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. The contents of the corrigenda 1 (March 2010) and 2 (June 2011) have been included in this copy. This consolidated version consists of the first edition (2009), its amendment 1 (2015) and its amendement 2 (june 2018). Therefore, no need to order amendment in addition to this publication.
국제분류(ICS)코드 11.040.50 : 방사선 및 기타 진단 기기
페이지수 321
Edition 1.2

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-2-54:2022상세보기 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 2022-09-26 표준
2 IEC 60601-2-54:2022 RLV상세보기 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 2022-09-26 표준
3 IEC 60601-2-54:2009+AMD1:2015+AMD2:2018 CSV상세보기 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 2018-06-29 구판
4 IEC 60601-2-54:2009/AMD2:2018상세보기 Amendment 2 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 2018-06-29 구판
5 IEC 60601-2-54:2009/AMD1:2015상세보기 Amendment 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 2015-04-17 구판
6 IEC 60601-2-54:2009+AMD1:2015 CSV상세보기 Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy 2015-04-17 구판
7 IEC 60601-2-54:2009/COR2:2011상세보기 Corrigendum 2 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 2011-06-10 구판
8 IEC 60601-2-54:2009/COR1:2010상세보기 Corrigendum 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 2010-03-10 구판
9 IEC 60601-2-54:2009상세보기 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 2009-06-29 구판

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