CEI UNI EN 1041 : 2014
Current
The latest, up-to-date edition.
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
Hardcopy , PDF
English - Italian
01-01-2014
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
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