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immediate downloadReleased: 2014-06-04
PD IEC/TR 80002-3:2014
Medical device software Process reference model of medical device software life cycle processes (IEC 62304)
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Standard number: | PD IEC/TR 80002-3:2014 |
Pages: | 32 |
Released: | 2014-06-04 |
ISBN: | 978 0 580 85976 2 |
Status: | Standard |
DESCRIPTION
PD IEC/TR 80002-3:2014
This standard PD IEC/TR 80002-3:2014 Medical device software is classified in these ICS categories:
- 11.040.01 Medical equipment in general
- 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.