PD IEC/TR 80002-3:2014 - Medical device software. Process reference model of medical device software life cycle processes (IEC 62304)

PD IEC/TR 80002-3:2014

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

Status : Current   Published : July 2014

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PDF

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HARDCOPY



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.




Standard NumberPD IEC/TR 80002-3:2014
TitleMedical device software. Process reference model of medical device software life cycle processes (IEC 62304)
StatusCurrent
Publication Date31 July 2014
Normative References(Required to achieve compliance to this standard)ISO/IEC 12207:2008, IEC 62304:2006
Informative References(Provided for Information)ISO 14971:2007, ISO/IEC 14764:2006, ISO/IEC 15288, ISO 13485:2003
International RelationshipsIEC/TR 80002-3:2014
DescriptorsMaintenance, Design, Risk assessment, Medical equipment, Equipment safety, Computer technology, Computer software, Electrical equipment, Software engineering techniques, Electrical medical equipment, Life (durability), Quality management, Hazards, Safety measures, Life cycle, Quality assurance systems
ICS11.040.01
CommitteeCH/62/1
ISBN978 0 580 85976 2
PublisherBSI
FormatA4
DeliveryYes
Pages32
File Size1.234 MB
Price£182.00


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