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DIN EN 13532:2002-08

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

German

Published date

01-01-2002

€59.63
Excluding VAT

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

This standard is included in DIN Handbook 378. 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
Pages
12
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
NF EN 13532 : 2002 Identical
NBN EN 13532 : 2002 Identical
NEN EN 13532 : 2002 Identical
NS EN 13532 : 1ED 2002 Identical
I.S. EN 13532:2002 Identical
UNE-EN 13532:2002 Identical
SN EN 13532 : 2002 Identical
UNI EN 13532 : 2002 Identical
BS EN 13532:2002 Identical
EN 13532:2002 Identical

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