NEN-EN 1041
Information supplied by the manufacturer with medical devices
inactive
| Organization: | NEN |
| Publication Date: | 1 March 1998 |
| Status: | inactive |
| Page Count: | 26 |
| ICS Code (Pharmaceutics in general): | 11.120.01 |
| ICS Code (Medical equipment in general): | 11.040.01 |
| ICS Code (Technical product documentation): | 01.110 |
scope:
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.
Document History
October 1, 2013
Information supplied by the manufacturer of medical devices
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
January 1, 2013
Information supplied by the manufacturer of medical devices
A description is not available for this item.
August 1, 2008
Information supplied by the manufacturer of medical devices
This standard specifies 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...
September 1, 2006
Information supplied by the manufacturer with medical devices
This standard specifies 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...
NEN-EN 1041
March 1, 1998
Information supplied by the manufacturer with medical devices
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...
September 1, 1995
Terminology, symbols and information provided with medical devices - Information supplied by the manufacturer with medical devices
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...