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IEC 62366-1:2015
Medical devices — Part 1: Application of usability engineering to medical devices- 발행일 : 2015-02-25
- 발행기관 : IEC
상세정보
| 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 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA IEC 62366-1:15 (R2020) + A1:21 (CONSOLIDATED)상세보기 | 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/AMD1:2020상세보기 | Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices | 2020-06-17 | 표준 |
| 3 | IEC 62366-1:2015+AMD1:2020 CSV상세보기 | Medical devices - Part 1: Application of usability engineering to medical devices | 2020-06-17 | 표준 |
| 4 | IEC 62366-1:2015/COR1:2016상세보기 | Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices | 2016-07-14 | 표준 |
| 5 | IEC 62366-1:2015상세보기 | Medical devices - Part 1: Application of usability engineering to medical devices | 2015-02-24 | 표준 |
| 6 | CSA IEC 62366-1:15 (R2020)상세보기 | 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 |
관련상품
- 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
- IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
- IEC TR 62366-2:2016 - Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
- IEC/TR 62366-2:2016 - Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
- IEC 62366-1:2015/COR1:2016 - Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices
다른 사람이 함께 구입한 상품
- IEC/TR 62366-2:2016 - Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
- DIN EN 1041:2013-12 - Information supplied by the manufacturer of medical devices (includes Amendment A1:2013)
- DIN EN ISO 10993-11:2018-09 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
- DIN EN ISO 11137-2:2015-11 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
- 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)
추천 상품
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- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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