관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
표준
판매
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 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 | 186 |
| Edition | 6.0 |
| 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
DIN EN ISO 10993-1:2017-04 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017 상세보기
BS EN 60601-1-6:2010+A1:2015 - Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability. 상세보기
BS EN IEC 60601-2-2:2018 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. 상세보기
BS EN 60601-2-10:2015+A1:2016 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. 상세보기
IEC 60601-2-27:2011 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
KS표준
핸드북
