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Reference IEC/TR 80002-3 ed1.0 withdrawn corrigendum
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Title Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
Publication date 2014-06-04
Format, price
(Swiss francs)
and language
170.- 28 pages
170.- 1118 Kb
 
Abstract 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.
Technical Committee 62A - Common aspects of electrical equipment used in medical practice  RSS
ICS Codes
11.040.01 Medical equipment in general
 
Replaced by
Stability date 2017
 
Work in progress
ProjectStage codeForecast publication date
No project under development--


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