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IEC/TR 80002-3 Ed. 1.0 en:2014
2014
Medical device software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
- Format:
- Language(s) :
- Published :
- English
- 06/04/2014
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.
| IEC/TR 80002-3 Ed. 1.0 en:2014 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | IEC/TR 80002-3 Ed. 1.0 en:2014 |
| Scope | Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304) |
| Publisher | IEC - International Electrotechnical Commission - Technical Report |
| Languages | English |
| State | |
| Publication Year | 2014 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| Edition | 1.0 |
| File Size | 1 file , 330 KB |
| Note | This product is unavailable in Russia, Belarus, Ukraine, Canada |
| Number of Pages | 28 |
| Published | 06/04/2014 |
| IEC/TR 80002-3 Ed. 1.0 en:2014 | ||
|---|---|---|
| History | Publisher Year | |
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