NF EN 13532 : 2002
Current
Current
GENERAL REQUIREMENTS FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR SELF-TESTING
Published date
01-12-2013
Publisher
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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.
| DevelopmentNote |
Indice de classement: S92-024. Supersedes NFS 92 024 (03/2004)
|
| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN 13532:2002 | Identical |
| UNE-EN 13532:2002 | Identical |
| EN 13532:2002 | Identical |
| DIN EN 13532:2002-08 | Identical |
Summarise
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