BS EN 1041 : 2008
Current
The latest, up-to-date edition.
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
Hardcopy , PDF
English
31-08-2008
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Requirements for provision of information
6 Documentation
Annex A (informative) - Requirements and guidance for
Directives 93/42/EEC and 90/385/EEC, as amended
Annex B (informative) - Guidance on alternative labelling for
instructions for use (IFU)
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EC
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 90/385/EC
Bibliography
Describes requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices.
| Committee |
CH/210/3
|
| DevelopmentNote |
Supersedes 93/502178 DC. (07/2005) Supersedes 06/30123163 DC. (09/2008) 2008 Edition Re-Issued in October 2013 & incorporates AMD 1 2013. Supersedes 13/30272487 DC. (10/2013)
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| I.S. EN 1041:2008+A1:2013 | Identical |
| NBN EN 1041 : 2008 + A1 2013 | Identical |
| EN 1041:2008+A1:2013 | Identical |
| NS EN 1041 : 2008 + A1 2013 | Identical |
| DIN EN 1041:2013-12 | Identical |
| NEN EN 1041 : 2008 + A1 2013 | Identical |
| EN 1041:2008 | Equivalent |
| DIN EN 1041:2008-11 | Equivalent |
| UNE-EN 1041:2009 | Identical |
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