I.S. EN 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
16-07-2020
English
01-01-2006
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
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