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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-1:2005+A1:2012 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. This consolidated version consists of the third edition (2005) and its amendment 1 (2012). Therefore, there is no need to order the amendment in addition to this publication. This document includes the contents of the corrigenda 1 (2006), 2 (2007) and 3 (2022), the contents of the corrigendum to Amendment 1 (2014), as well as the interpretation sheets 1 (2008), 2 (2009), 3 (2013) and interpretation sheet to amendment 1 (2021). IEC TR 62348:2012 provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012, and to trace requirements between the third edition and the amended second edition. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 1660 |
| Edition | 3.1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-1:2024 SER | Medical electrical equipment - ALL PARTS | 2024-01-09 | 표준 |
| 2 | IEC 60601-1:2005/COR3:2022 | Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2022-12-09 | 표준 |
| 3 | IEC 60601-1:2005/AMD2:2020 | Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2020-08-20 | 표준 |
| 4 | IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2020-08-20 | 표준 |
| 5 | IEC 60601-1:2005/AMD1:2012/COR1:2014 | Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2014-07-22 | 표준 |
| 6 | IEC 60601-1:2005+AMD1:2012 CSV/COR1:2012 | Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2012-11-14 | 표준 |
| 7 | IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2012-08-20 | 표준 |
| 8 | IEC 60601-1:2005/AMD1:2012 | Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2012-07-13 | 표준 |
| 9 | IEC 60601-1:2005/COR2:2007 | Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2007-12-07 | 표준 |
| 10 | IEC 60601-1:2005/COR1:2006 | Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2006-12-12 | 표준 |
| 11 | IEC 60601-1:2005 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2005-12-15 | 표준 |
| 12 | IEC 60601-1:1988/AMD2:1995/COR1:1995 | Corrigendum 1 to Amendment 2 - Medical electrical equipment - Part 1: General requirements for safety | 1995-06-01 | 구판 |
| 13 | IEC 60601-1:1988/AMD2:1995 | Amendment 2 - Medical electrical equipment - Part 1: General requirements for safety | 1995-03-07 | 구판 |
| 14 | IEC 60601-1:1988/AMD1:1991 | Amendment 1 - Medical electrical equipment - Part 1: General requirements for safety | 1991-11-13 | 구판 |
| 15 | IEC 60601-1:1988 | Medical electrical equipment - Part 1: General requirements for safety | 1988-12-30 | 구판 |
| 16 | IEC 60601-1:1977/AMD1:1984 | Amendment 1 - Medical electrical equipment. Part 1: General requirements. | 1984-01-01 | 구판 |
| 17 | IEC 60601-1:1977 | Medical electrical equipment. Part 1: General requirements. | 1977-01-01 | 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
BS EN ISO 14971:2012 - Medical devices. Application of risk management to medical devices. 상세보기
IEC 60601-2-47:2012 - Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems 상세보기
BS EN 60601-2-47:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. 상세보기
BS EN 60601-2-27:2014 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. 상세보기
BS EN 60601-2-25:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographs. 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
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