NEN EN 13532 : 2002
Current
The latest, up-to-date edition.
GENERAL REQUIREMENTS FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR SELF-TESTING
12-01-2013
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 |
Netherlands Standards
|
| 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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