AAMI/IEC TIR80002-1:2009
Current
The latest, up-to-date edition.
MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE
Hardcopy , PDF
English
26-10-2009
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC TIR8002-1:2009
FOREWORD
INTRODUCTION
1 General
2 Terms and definitions
3 General requirements for RISK MANAGEMENT
4 RISK ANALYSIS
5 RISK EVALUATION
6 RISK CONTROL
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and POST-PRODUCTION information
Annex A (informative) - Discussion of definitions
Annex B (informative) - Examples of software causes
Annex C (informative) - Potential software-related pitfalls
Annex D (informative) - Life-cycle/risk management grid
Annex E (informative) - SAFETY cases
Bibliography
Index
Index of defined terms
This technical document provides information useful for the performance of effective software risk management, as part of the overall risk management process for medical devices containing software.
| Committee |
SW
|
| DocumentType |
Guide
|
| ISBN |
1-57020-371-7
|
| Pages |
80
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| IEC TR 80002-1:2009 | Identical |
| AAMI TIR69 : 2017 | RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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