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UNI EN 1041 : 2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INFORMATION SUPPLIED BY THE MANUFACTURE WITH MEDICAL DEVICES
Superseded date

01-09-2011

Published date

01-01-2000

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 the information for supplying by a manufacturer for different categories of medical devices as required by the relevant EU Directives. Does not define the language to be used for such information. Meant to complement the specified requirements of the EU Directives on medical devices in the context of defining means where certain requirements may be met.

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy

Standards Relationship
ONORM EN 1041 : 2013 Identical
I.S. EN 1041:2008+A1:2013 Identical
CEI UNI EN 1041 : 2014 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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