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NS EN 13532 : 1ED 2002

Current

Current

The latest, up-to-date edition.

GENERAL REQUIREMENTS FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR SELF-TESTING

Published date

12-01-2013

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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design criteria
5 Markings and information supplied by the manufacturer
6 Performance evaluation
7 User verification
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

Defines general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Current

Standards Relationship
UNE-EN 13532:2002 Identical
BS EN 13532:2002 Identical
UNI EN 13532 : 2002 Identical
EN 13532:2002 Identical
DIN EN 13532:2002-08 Identical

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