PD IEC/TR 80002-3:2014
Current
The latest, up-to-date edition.
Medical device software Process reference model of medical device software life cycle processes (IEC 62304)
Hardcopy , PDF
English
04-06-2014
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/62/1
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| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
British Standards Institution
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| Status |
Current
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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.
| Standards | Relationship |
| IEC TR 80002-3:2014 | Identical |
| ISO/IEC 14764:2006 | Software Engineering — Software Life Cycle Processes — Maintenance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO/IEC 15288:2008 | Systems and software engineering — System life cycle processes |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO/IEC 12207:2008 | Systems and software engineering — Software life cycle processes |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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