AAMI TIR45 : 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE
Hardcopy , PDF
English
01-01-2012
23-07-2013
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Superseded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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