AAMI/ISO TIR 80002-2:2017
Current
The latest, up-to-date edition.
MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS
English
18-08-2017
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TR 80002-2
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Software validation discussion
5 Software validation and critical thinking
6 Documentation
7 Prerequisite processes
Annex A (informative) - Toolbox
Annex B (informative) - Risk management
and risk-based approach
Annex C (informative) - Examples
Bibliography
Pertains to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
| Committee |
ISO/TC 210
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-670-2
|
| Pages |
103
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| ISO/TR 80002-2:2017 | Identical |
| IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| 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 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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