I.S. EN 62304:2006
Superseded
View Superseded by
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
Hardcopy , PDF
English - French
01-01-2006
07-16-2020
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
European foreword
FOREWORD
INTRODUCTION
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
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EC Directives
Bibliography
Index of defined terms
This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE.
| Committee |
ISO/IEC JTC 1
|
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| ISBN |
2-8318-8637-6
|
| Pages |
176
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 62304 : 2007 | Identical |
| DIN EN 62304:2016-10 | Identical |
| IEC 62304:2006+AMD1:2015 CSV | Identical |
| BS EN 62304 : 2006 | Identical |
| EN 62304:2006 | Equivalent |
| IEC 62304:2006 | Equivalent |
| UNE-EN 62304:2007 | Identical |
| NF EN 62304 : 2006 AMD 1 2018 | Identical |
A newer version of this standard is available.
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