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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
| 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 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-2-2:2017/AMD1:2023 | 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 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 | 2023-02-21 | 표준 |
| 3 | IEC 60601-2-2:2017 RLV | 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 60601-2-2:2017 | 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/COR1:2014 | 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 60601-2-2:2009 | 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 60601-2-2:2006 | Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment | 2006-07-19 | 구판 |
| 8 | IEC 60601-2-2:1998 | Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment | 1998-09-23 | 구판 |
| 9 | IEC 60601-2-2:1991 | Medical electrical equipment - Part 2: Particular requirements for the safety of high frequency surgical equipment | 1991-10-31 | 구판 |
| 10 | IEC 60601-2-2:1982 | Medical electrical equipment - Part 2: Particular requirements for the safety of high-frequency surgical equipment | 1982-01-01 | 구판 |
IEC/DIS 60601-2-26 - Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs 상세보기
IEC 60601-2-15:1988 - Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators 상세보기
IEC 60601-2-14:1989 - Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment 상세보기
IEC 60601-2-32:1994 - Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment 상세보기
IEC 60601-1-4:1996 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems 상세보기
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