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AAMI/IEC TIR80002-3:2016

AAMI/IEC TIR80002-3:2016

Technical Information Report Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

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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.

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