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|분야||ISO/TC 210 : Quality management and corresponding general aspects for medical devices|
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971.
|국제분류(ICS)코드||11.040.01 : 일반 의료장비|
|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(REDLINE)||Medical devices -- Application of risk management to medical devices||2019-12-10||표준|
|3||ISO 14971:2019||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||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/TR 24971:2020 - Medical devices -- Guidance on the application of ISO 14971 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process 상세보기
ISO 11737-2:2019 - Sterilization of health care products -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process 상세보기
ISO 11607-2:2019 - Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes 상세보기
ISO 13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes 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