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AAMI/IEC TIR80002-1:2009

Current

Current

The latest, up-to-date edition.

MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-26-2009

US$275.00
Excluding Tax where applicable

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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