I.S. EN 1041:2008+A1:2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Requirements for provision of information
6 Documentation
Annex A (informative) - Requirements and guidance for
        Directives 93/42/EEC and 90/385/EEC, as amended
Annex B (informative) - Guidance on alternative labelling for
        instructions for use (IFU)
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EC
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 90/385/EC
Bibliography

Describes 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 Council Directive 93/42/EEC concerning medical devices.