99.60 Withdrawal effective Aug 6, 2008
CEN/CENELEC
CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices
European Norm
01.110 Technical product documentation | 11.040.01 Medical equipment in general | 11.120.01 Pharmaceutics in general
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.
Legislation related to this standard
Active implantable medical devices
Harmonised Standard / Cited in the Official Journal
WITHDRAWN
EN 1041:1998
99.60
Withdrawal effective
Aug 6, 2008
WITHDRAWN
EN 1041:2008
