Codes & Standards - Purchase
IEC TR 80002-3:2014
- 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.