IEC TR 80002-3
Medical device software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
|Publication Date:||1 June 2014|
|ICS Code (Medical equipment in general):||11.040.01|
This part of IEC 80002, 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 PRM 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.