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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 60601-1-6:2010+A1:2013+A2:2020 specifies a process for a manufacturer toanalyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. This consolidated version consists of the third edition (2010), its amendment 1 (2013) and its amendment 2 (2020). Therefore, no need to order amendments in addition to this publication. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 93 |
| Edition | 3.2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-1-6:2010/AMD2:2020 | Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 2020-07-22 | 표준 |
| 2 | IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 2020-07-22 | 표준 |
| 3 | IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 2013-10-29 | 표준 |
| 4 | IEC 60601-1-6:2010/AMD1:2013 | Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 2013-10-29 | 표준 |
| 5 | IEC 60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 2010-01-27 | 표준 |
| 6 | IEC 60601-1-6:2006 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 2006-12-08 | 구판 |
| 7 | IEC 60601-1-6:2004 | Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability | 2004-06-24 | 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
IEC 62366-1:2015+AMD1:2020 CSV - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
IEC 60601-1-2:2014+AMD1:2020 CSV - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests 상세보기
IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 상세보기
IEC 60601-1-2:2014+AMD1:2020 CSV - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests 상세보기
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 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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