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AAMI TIR45 : 2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE
Available format(s)

Hardcopy , PDF

Superseded date

07-23-2013

Language(s)

English

Published date

01-01-2012

Glossary of equivalent standards
Committee representation
Foreword
Introduction
Why read this TIR?
Initial recommendations
1 Scope
2 References
3 Terms and definitions
4 Setting the stage
5 Aligning on concepts
6 Aligning on Practices
Bibliography

Specifies perspectives on the application of AGILE during medical device software development.

Committee
SW
DocumentType
Standard
Pages
74
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
IEEE 828-2012 IEEE Standard for Configuration Management in Systems and Software Engineering
ISO/IEC 20926:2009 Software and systems engineering — Software measurement — IFPUG functional size measurement method 2009
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO/IEC/IEEE 24765:2017 Systems and software engineering — Vocabulary
ISO/IEC 20000-1:2011 Information technology Service management Part 1: Service management system requirements
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
AAMI IEC 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
ISO 14971:2007 Medical devices Application of risk management to medical devices

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