AAMI/IEC TIR80002-3:2016
Current
The latest, up-to-date edition.
MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304)
English
12-08-2016
Glossary of equivalent standards
Committee representation
Background of AAMI/IEC TIR80002-3:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Medical device software life cycle processes
Annex A (informative) - Development of this
technical report
Annex B (informative) - Mapping between IEC
62304:2006 and ISO/IEC 12207:2008
Bibliography
This part of IEC 80002, which is a technical report (TR), provides the description of software life cycle processes for medical devices.
| DocumentType |
Technical Report
|
| ISBN |
1-57020-619-8
|
| Pages |
36
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| IEC TR 80002-3:2014 | Identical |
| ISO/IEC 14764:2006 | Software Engineering — Software Life Cycle Processes — Maintenance |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO/IEC 15288:2008 | Systems and software engineering — System life cycle processes |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO/IEC 12207:2008 | Systems and software engineering — Software life cycle processes |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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