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Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | IEC TR 62366-2:2016(E), which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 94 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC TR 62366-2:2016 | Medical devices - Part 2: Guidance on the application of usability engineering to medical devices | 2016-04-27 | 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 62366-1:2015/COR1:2016 - Corrigendum 1 - 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
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
IEC 62366-1:2015(KS P IEC 62366-1) - 의료기기 — 제1부:의료기기에 대한 사용성 공학 적용 상세보기
IEC 62366-1:2015+AMD1:2020 CSV - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
IEC 62366-1:2015/AMD1:2020 - Amendment 1 - Medical devices - Part 1: Application of usability engineering 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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