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Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
| 분야 | TC 62/SC 62A : Common aspects of medical equipment, software, and systems |
|---|---|
| 적용범위 | IEC TR 80002-3:2014 which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010. The content of these three standards provides the foundation of this TR. This TR does not: - address areas already covered by existing related standards, e.g. the international standards that relate to the four standards used to build this TR (see Bibliography); - FDA guidance documents; or - software development tools. This TR describes the process reference model for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006. The process names correspond to those of IEC 62304:2006. The mappings provided in Annex B are essential for the alignment between IEC 62304:2006 (which is based on ISO/IEC 12207:1995) and ISO/IEC 12207:2008, developed to address the detailed normative relationship between the two standards. This technical report 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 | 28 |
| Edition | 1.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC TR 80002-3:2014 | Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304) | 2014-06-04 | 폐지 |
IEC TR 80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software 상세보기
IEC/TR 80002-1:2009 - 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 80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software 상세보기
ISO/TR 80002-2:2017 - Medical device software — Part 2: Validation of software for medical device quality systems 상세보기
IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
IEC 62304:2006+AMD1:2015 CSV - Medical device software - Software life cycle processes 상세보기
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
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