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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.01 Medical equipment in general>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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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)

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
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.
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