AAMI IEC 62304 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
English
08-06-2006
13-09-2021
Glossary of equivalent standards
Committee representation
Foreword
Introduction
Introduction to Amendment 1
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Software development PROCESS
6 Software maintenance PROCESS
7 Software RISK MANAGEMENT PROCESS
8 Software configuration management
PROCESS
9 Software problem resolution PROCESS
Annex A (informative) - Rationale for the
requirements of this standard
Annex B (informative) - Guidance on the
provisions of this standard
Annex C (informative) - Relationship to
other standards
Annex D (informative) - Implementation
Bibliography
Index of defined terms
Describes the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.
| DevelopmentNote |
Supersedes AAMI SW68 (08/2006)
|
| DocumentType |
Standard
|
| Pages |
181
|
| ProductNote |
NEW CHILD AMD 1 IS ADDED
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 62304:2006+AMD1:2015 CSV | Identical |
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