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    IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 CSV

    Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
    • 발행일 : 2022-08-02
    • 발행기관 : IEC
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분야 TC 62/SC 62B : Medical imaging equipment, software, and systems
적용범위 IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 CSV applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.
국제분류(ICS)코드 11.040.50 : 방사선 및 기타 진단 기기
페이지수 228
Edition 3.2

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-2-45:2011/AMD2:2022상세보기 Amendment 2 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 2022-08-02 표준
2 IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 CSV상세보기 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 2022-08-02 표준
3 IEC 60601-2-45:2011+AMD1:2015 CSV상세보기 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 2015-06-18 표준
4 IEC 60601-2-45:2011/AMD1:2015상세보기 Amendment 1 - Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 2015-06-18 표준
5 IEC 60601-2-45:2011상세보기 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 2011-02-10 표준
6 IEC 60601-2-45:2001상세보기 Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices 2001-05-29 구판
7 IEC 60601-2-45:1998상세보기 Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices 1998-09-17 구판

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