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CEI UNI EN 1041 : 2013

NA
NA

Status of Standard is Unknown

INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2013

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

Defines 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.

DocumentType
Standard
Pages
30
PublisherName
Comitato Elettrotecnico Italiano
Status
NA

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