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eLibrary > 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) >

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), 2016

AAMI/IEC TIR80002-3:2016, Medical device software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
Title page
Copyright information
AAMI Technical Information Report
ANSI Registration
Contents
Glossary of equivalent standards
Committee representation
Background of AAMI/IEC TIR80002-3:2016
Foreword
Introduction [Go to Page]
0.1 Background
0.2 Organization of this technical report
1 Scope
2 Normative references
3 Terms and definitions
4 Medical device software life cycle processes [Go to Page]
4.1 Software development process [Go to Page]
4.1.1 Software development planning [Go to Page]
4.1.1.1 Purpose
4.1.1.2 Outcomes
4.1.2 Software requirements analysis [Go to Page]
4.1.2.1 Purpose
4.1.2.2 Outcomes
4.1.3 Software architectural design [Go to Page]
4.1.3.1 Purpose
4.1.3.2 Outcomes
4.1.4 Software detailed design [Go to Page]
4.1.4.1 Purpose
4.1.4.2 Outcomes
4.1.5 Software unit implementation and verification [Go to Page]
4.1.5.1 Purpose
4.1.5.2 Outcomes
4.1.6 Software integration and integration testing [Go to Page]
4.1.6.1 Purpose
4.1.6.2 Outcomes
4.1.7 Software system testing [Go to Page]
4.1.7.1 Purpose
4.1.7.2 Outcomes
4.1.8 Software release [Go to Page]
4.1.8.1 Purpose
4.1.8.2 Outcomes
4.2 Software maintenance [Go to Page]
4.2.1 Purpose
4.2.2 Outcomes
4.3 Software risk management [Go to Page]
4.3.1 Purpose
4.3.2 Outcomes
4.4 Software configuration management [Go to Page]
4.4.1 Purpose
4.4.2 Outcomes
4.5 Software problem resolution [Go to Page]
4.5.1 Purpose
4.5.2 Outcomes
Annex A (informative) Development of this technical report [Go to Page]
Figure A.1 – Requirements in process elements of IEC 62304:2006 and ISO/IEC 12207:2008
Figure A.2 – Development of process outcomes for medical device software development PRM
Table A.1 – Direct process mappings between IEC 62304:2006 and ISO/IEC 12207:2008
Annex B (informative) Mapping between IEC 62304:2006 and ISO/IEC 12207:2008 [Go to Page]
Table B.1 – Mapping between process outcomes of the PRM and the requirements of IEC 62304:2006, including their safety classes, and the requirements of ISO/IEC 12207:2008
Bibliography [Go to Page]

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