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    IEC 60601-2-37:2024

    Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
    • 발행일 : 2024-07-02
    • 발행기관 : IEC
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분야 TC 62/SC 62B : Medical imaging equipment, software, and systems
적용범위 IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx,
b) technical and editorial changes as a result of maintenance to normative references;
c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.
국제분류(ICS)코드 17.140.50 : 전자 음향
11.040.55 : 진단장비
페이지수 118
Edition 3.0

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-2-37:2024상세보기 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment 2024-07-02 표준
2 IEC 60601-2-37:2024 RLV상세보기 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment 2024-07-02 표준
3 IEC 60601-2-37:2007/AMD1:2015상세보기 Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment 2015-06-08 구판
4 IEC 60601-2-37:2007+AMD1:2015 CSV상세보기 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment 2015-06-08 구판
5 IEC 60601-2-37:2007상세보기 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment 2007-08-09 구판
6 IEC 60601-2-37:2001/AMD2:2005상세보기 Amendment 2 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment 2005-11-28 구판
7 IEC 60601-2-37:2001+AMD1:2004 CSV상세보기 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment 2004-10-14 구판
8 IEC 60601-2-37:2001/AMD1:2004상세보기 Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment 2004-08-23 구판
9 IEC 60601-2-37:2001상세보기 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment 2001-07-24 구판

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