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Medical devices - Part 1: Application of usability engineering to medical devices
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC 62366-1:2015+A1:2020 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks 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. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2 (not published yet), cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1:2014. Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2, once published, will contain tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces. The contents of the corrigendum of July 2016 have been included in this copy. This consolidated version consists of the first edition (2015) and its amendment 1 (2020). Therefore, no need to order amendment in addition to this publication. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 246 |
| Edition | 1.1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA IEC 62366-1:15 (R2020) + A1:21 (CONSOLIDATED) | Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, edition 1:2015 consolidated with amendment 1:2020) | Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation a | 2022-01-01 | 표준 |
| 2 | IEC 62366-1:2015/AMD1:2020 | Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices | 2020-06-17 | 표준 |
| 3 | IEC 62366-1:2015+AMD1:2020 CSV | Medical devices - Part 1: Application of usability engineering to medical devices | 2020-06-17 | 표준 |
| 4 | IEC 62366-1:2015/COR1:2016 | Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices | 2016-07-14 | 표준 |
| 5 | IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices | 2015-02-24 | 표준 |
| 6 | CSA IEC 62366-1:15 (R2020) | Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, first edition, 2015-02) | Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation aux dispositifs médicaux (no | 2015-01-01 | 표준 |
CSA IEC 62366-1:15 (R2020) - Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, first edition, 2015-02) | Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation aux dispositifs médicaux (no 상세보기
IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
IEC 62366-1:2015 - Medical devices — Part 1: Application of usability engineering to medical devices 상세보기
IEC TR 62366-2:2016 - Medical devices - Part 2: Guidance on the application of usability engineering to medical devices 상세보기
IEC/TR 62366-2:2016 - Medical devices — Part 2: Guidance on the application of usability engineering to medical devices 상세보기
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 상세보기
IEC TR 62366-2:2016 - Medical devices - Part 2: Guidance on the application of usability engineering to medical devices 상세보기
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
ISO/TR 24971:2020 - Medical devices — Guidance on the application of ISO 14971 상세보기
IEC 62304:2006+AMD1:2015 CSV - Medical device software - Software life cycle processes 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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