UNI EN 1041 : 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.