I.S. EN 13532:2002
Current
The latest, up-to-date edition.
GENERAL REQUIREMENTS FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR SELF-TESTING
Hardcopy , PDF
English
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
Specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing.
| DocumentType |
Standard
|
| Pages |
9
|
| PublisherName |
National Standards Authority of Ireland
|
| 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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