I.S. EN ISO 15883-6:2015
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
01-01-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical and control requirements
6 Testing for conformity
7 Information to be supplied by the manufacturer
8 Information to be requested from the purchaser by the
supplier of the WD
Annex A (informative) - Summary of test programmes
Bibliography
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on medical devices
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