I.S. EN 62304:2006&A1:2015
Current
The latest, up-to-date edition.
Medical device software - Software life-cycle processes (IEC 62304:2006/A1:2015)
Hardcopy , PDF
English - French
03-11-2015
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.
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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
Bibliography
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