DIN EN 13532:2002-08
Current
The latest, up-to-date edition.
GENERAL REQUIREMENTS FOR IN-VITRO DIAGNOSTIC MEDICAL DEVICES FOR SELF-TESTING
Hardcopy , PDF
German
01-01-2002
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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
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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