UNI EN 1041 : 2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INFORMATION SUPPLIED BY THE MANUFACTURE WITH MEDICAL DEVICES
01-09-2011
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Superseded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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.