CEI UNI EN 1041 : 2014
Superseded
View Superseded by
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
Hardcopy , PDF
English - Italian
01-01-2014
15-07-2025
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.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-151. (05/2009)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 1041:2008+A1:2013 | Identical |
A newer version of this standard is available.
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