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IEC/TR 80002-3-ed.1.0
Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
STANDARD published on 4.6.2014
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The information about the standard:
Designation standards: IEC/TR 80002-3-ed.1.0
Publication date standards: 4.6.2014
SKU: NS-407982
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: International technical standard
The category - similar standards:
Annotation of standard text IEC/TR 80002-3-ed.1.0 :
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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