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Medical devices — Application of risk management to medical devices
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 82 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA ISO 14971:21 | Medical devices – Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12) | 2021-01-01 | 표준 |
| 2 | ISO 14971:2019 | Medical devices — Application of risk management to medical devices | 2019-12-10 | 표준 |
| 3 | ISO 14971:2019(REDLINE) | Medical devices — Application of risk management to medical devices | 2019-12-10 | 표준 |
| 4 | ISO 14971:2007 | Medical devices — Application of risk management to medical devices | 2007-02-28 | 구판 |
| 5 | ISO 14971:2000/Amd 1:2003 | Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements | 2003-02-19 | 구판 |
| 6 | ISO 14971:2000 | Medical devices — Application of risk management to medical devices | 2000-11-30 | 구판 |
관련상품이 존재하지 않습니다.
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes 상세보기
IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
BS EN 60601-2-49:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment. 상세보기
BS EN ISO 14971:2012 - Medical devices. Application of risk management 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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