NEN EN 1041 : 2008 + A1 2013
Current
The latest, up-to-date edition.
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
12-01-2013
1 Scope
2 Normative references
3 Definitions
4 Requirements for information to be supplied by the
manufacturer
Annex A (informative) Bibliography
Annex B (informative) Requirements and guidance for active
implantable medical devices
Annex C (informative) Requirements and guidance for medical
devices
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
Council Directive 90/385/EEC relating to active implantable
medical devices
Annex ZB (informative) Clauses of this European Standard
addressing essential requirements or other provisions of
Council Directive 93/42/EEC concerning medical devices
Defines 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.
| DevelopmentNote |
2008 Edition Re-Issued in October 2013 & incorporates AMD 1 2013. (10/2013)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| I.S. EN 1041:2008+A1:2013 | Identical |
| EN 1041:2008+A1:2013 | Identical |
| DIN EN 1041:2013-12 | Identical |
| UNE-EN 1041:2009 | Identical |
| BS EN 1041 : 2008 | Identical |