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PD IEC/TR 80002-3:2014



The latest, up-to-date edition.

Medical device software Process reference model of medical device software life cycle processes (IEC 62304)

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British Standards Institution

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.

Standards Relationship
IEC TR 80002-3:2014 Identical

ISO/IEC 14764:2006 Software Engineering Software Life Cycle Processes Maintenance
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO/IEC 15288:2008 Systems and software engineering System life cycle processes
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
ISO 14971:2007 Medical devices Application of risk management to medical devices

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