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AAMI/IEC TIR80002-3:2016

Current
Current

The latest, up-to-date edition.

MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-12-2016

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
Standard
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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