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Medical devices — Part 1: Application of usability engineering to medical devices
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | IEC 62366-1:2015 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, 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 contains 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. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 96 |
| Edition | 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 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 62366-1:2015/COR1:2016 - Corrigendum 1 - 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
DIN EN 1041:2013-12 - Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) 상세보기
DIN EN ISO 10993-11:2018-09 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017) 상세보기
DIN EN ISO 11137-2:2015-11 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) 상세보기
DIN EN ISO 11137-3:2017-11 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017) 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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