RO
SR EN 1041:2003
Information supplied by the manufacturer with medical devices
This standard specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.
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Status :
Withdrawn
Approval date : 8/25/2003
Publish date : 8/26/2003
Withdrawal date : 1/30/2009
Number of pages : 28
ICS : 01.110 Technical product documentation,11.040.01 Medical equipmet in general,11.120.01 Pharmaceutics in general
Technical Committee : 377 - Medical devices
- Replaced by SR EN 1041:2009