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NEN EN 1041 : 2008 + A1 2013

Current
Current

The latest, up-to-date edition.

INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
Published date

01-12-2013

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
ONORM EN 1041 : 2013 Identical
I.S. EN 1041:2008+A1:2013 Identical
UNE-EN 1041:2009 Identical
EN 1041:2008+A1:2013 Identical
DIN EN 1041:2013-12 Identical
BS EN 1041 : 2008 Identical

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