AAMI TIR80002 3 2016
$115.49
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)
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 36 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/IEC TIR80002-3:2016, Medical device software—Part 3: Process reference model of medical device software life cycle processes (IEC 62304) |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Registration |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of AAMI/IEC TIR80002-3:2016 |
| 11 | Foreword |
| 13 | Introduction 0.1 Background 0.2 Organization of this technical report |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 16 | 4 Medical device software life cycle processes 4.1 Software development process 4.1.1 Software development planning 4.1.1.1 Purpose 4.1.1.2 Outcomes |
| 17 | 4.1.2 Software requirements analysis 4.1.2.1 Purpose 4.1.2.2 Outcomes 4.1.3 Software architectural design 4.1.3.1 Purpose 4.1.3.2 Outcomes |
| 18 | 4.1.4 Software detailed design 4.1.4.1 Purpose 4.1.4.2 Outcomes 4.1.5 Software unit implementation and verification 4.1.5.1 Purpose 4.1.5.2 Outcomes 4.1.6 Software integration and integration testing 4.1.6.1 Purpose 4.1.6.2 Outcomes |
| 19 | 4.1.7 Software system testing 4.1.7.1 Purpose 4.1.7.2 Outcomes 4.1.8 Software release 4.1.8.1 Purpose 4.1.8.2 Outcomes |
| 20 | 4.2 Software maintenance 4.2.1 Purpose 4.2.2 Outcomes 4.3 Software risk management 4.3.1 Purpose |
| 21 | 4.3.2 Outcomes 4.4 Software configuration management 4.4.1 Purpose 4.4.2 Outcomes |
| 22 | 4.5 Software problem resolution 4.5.1 Purpose 4.5.2 Outcomes |
| 24 | Annex A (informative) Development of this technical report Figure A.1 – Requirements in process elements of IEC 62304:2006 and ISO/IEC 12207:2008 |
| 25 | 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 |
| 26 | Annex B (informative) Mapping between IEC 62304:2006 and ISO/IEC 12207:2008 |
| 27 | 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 |
| 36 | Bibliography |
