관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
표준
판매
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on medical devices, this technical report may be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1:2009 is not intended to be used as the basis of regulatory inspection or certification assessment activities. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 64 |
| Edition | 1.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software | 2009-09-23 | 표준 |
IEC/TR 80002-1:2009 - Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software 상세보기
IEC TR 80002-3:2014 - Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304) 상세보기
IEC/TR 80002-3:2014 - Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304) 상세보기
ISO/TR 80002-2:2017 - Medical device software — Part 2: Validation of software for medical device quality systems 상세보기
IEC TR 80002-3:2014 - Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304) 상세보기
IEC 82304-1:2016 - Health software - Part 1: General requirements for product safety 상세보기
IEC 62304:2006+AMD1:2015 CSV - Medical device software - Software life cycle processes 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
KS표준
핸드북
