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    IEC 60601-2-2:2017+AMD1:2023 CSV

    Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    • 발행일 : 2023-02-21
    • 발행기관 : IEC
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분야 TC 62/SC 62D : Particular medical equipment, software, and systems
적용범위 IEC 60601-2-2:2017+AMD1:2023 CSV applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories.
HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.
The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
- refinement and additions to the defined terms;
- additional separation of the requirements for HF surgical equipment and HF surgical accessories;
- a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;
- new requirements for devices that have or use a high current mode.
국제분류(ICS)코드 11.040.30 : 외과장비
페이지수 378
Edition 6.1

이력정보

No. 표준번호 표준명 발행일 상태
1 IEC 60601-2-2:2017/AMD1:2023상세보기 Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 2023-02-21 표준
2 IEC 60601-2-2:2017+AMD1:2023 CSV상세보기 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 2023-02-21 표준
3 IEC 60601-2-2:2017 RLV상세보기 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 2017-03-31 표준
4 IEC 60601-2-2:2017상세보기 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 2017-03-31 표준
5 IEC 60601-2-2:2009/COR1:2014상세보기 Corrigendum 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 2014-02-19 구판
6 IEC 60601-2-2:2009상세보기 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories 2009-02-23 구판
7 IEC 60601-2-2:2006상세보기 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment 2006-07-19 구판
8 IEC 60601-2-2:1998상세보기 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment 1998-09-23 구판
9 IEC 60601-2-2:1991상세보기 Medical electrical equipment - Part 2: Particular requirements for the safety of high frequency surgical equipment 1991-10-31 구판
10 IEC 60601-2-2:1982상세보기 Medical electrical equipment - Part 2: Particular requirements for the safety of high-frequency surgical equipment 1982-01-01 구판

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