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
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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
Specifies guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software - Software life cycle processes.
| Committee |
SW
|
| DocumentType |
Technical Report
|
| 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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