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AAMI TIR80002-3:2016

Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
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AAMI TIR80002-3:2016

Medical Device Software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

PUBLISH DATE 2016
AAMI TIR80002-3:2016
Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires well designed software that fulfils its purpose without causing any unacceptable risks. Following an internationally approved set of software development practices provides one way of achieving this. This technical report (TR) provides a framework of life cycle processes supporting the safe design and maintenance of medical device software called the process reference model (PRM). The process descriptions in this PRM are fully compliant with the requirements of ISO/IEC 24774:2010, Systems and software engineering — Life cycle management — Guidelines for process description. This TR presents the PRM for medical device software development as a result of integrating requirements from IEC 62304:2006 and from the international standard of software life-cycle processes ISO/IEC 12207:2008.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR80002-3
Publication Date May 1, 2016
Language en - English
Page Count 36
Revision Level
Supercedes
Committee
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