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I.S. EN 62304:2006&A1:2015

Current
Current

The latest, up-to-date edition.

Medical device software - Software life-cycle processes (IEC 62304:2006/A1:2015)
Available format(s)

Hardcopy , PDF

Language(s)

English - French

Published date

11-03-2015

Preview

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE.

Committee
TC 62
DocumentType
Standard
ISBN
978-2-8322-2720-6
Pages
220
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
EN 62304:2006/A1:2015 Identical

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