IEC TR 80002-3:2014
Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
- 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.
|Publication type||Technical Report|
|TC/SC||TC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss|
|ICS||11.040.01 - Medical equipment in general|
|File size||1118 KB|
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