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Medical devices - Application of usability engineering to medical devices
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. 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 International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 209 |
| Edition | 1.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 62366:2007/AMD1:2014 | Amendment 1 - Medical devices - Application of usability engineering to medical devices | 2014-01-28 | 폐지(대체) |
| 2 | IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices | 2014-01-28 | 폐지(대체) |
| 3 | IEC 62366:2007 | Medical devices - Application of usability engineering to medical devices | 2007-10-18 | 폐지(대체) |
관련상품이 존재하지 않습니다.
ISO 14971:2007 - Medical devices — Application of risk management to medical devices 상세보기
IEC 61000-3-3:2013 - Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤16 A per phase and not subject to conditional connection 상세보기
IEC 60601-1:2005+AMD1:2012 CSV - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 상세보기
BS EN ISO 10993-1:October 2009 - Biological evaluation of medical devices. Evaluation and testing within a risk management process. 상세보기
BS EN 1041:2008+A1:2013 - Information supplied by the manufacturer of 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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