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
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