I.S. EN 13532:2002
Current
GENERAL REQUIREMENTS FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR SELF-TESTING
Hardcopy , PDF
English
01-01-2002
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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 |
| BS EN 13532:2002 | Identical |
| UNE-EN 13532:2002 | Identical |
| EN 13532:2002 | Identical |
| DIN EN 13532:2002-08 | Identical |
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