BS EN 62304 : 2006
Current
The latest, up-to-date edition.
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
Hardcopy , PDF
English
01-01-2006
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
Specifies 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.
| Committee |
CH/62/1
|
| DevelopmentNote |
Supersedes 04/30089749 DC (11/2006) 2006 Edition Re-Issued in November 2015 & incorporates AMD 1 2015. 2006 Edition along with its corrigendum is still active & will be withdrawn on 31/07/2018. Supersedes 14/30287753 DC. (11/2015)
|
| DocumentType |
Standard
|
| Pages |
88
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NBN EN 62304 : 2007 | Identical |
| DIN EN 62304:2016-10 | Identical |
| IEC 62304:2006+AMD1:2015 CSV | Identical |
| I.S. EN 62304:2006 | Identical |
| EN 62304:2006 | Equivalent |
| UNE-EN 62304:2007 | Identical |
| NF EN 62304 : 2006 AMD 1 2018 | Identical |
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