UNI EN 13975 : 2003
Current
The latest, up-to-date edition.
SAMPLING PROCEDURES USED FOR ACCEPTANCE TESTING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES - STATISTICAL ASPECTS
01-09-2003
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedures
Annex A (informative) General notes
Annex ZA (informative) Clauses of this European Standard
addressing requirements of EU Directives
Bibliography
Covers sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN 13975:2003 | Identical |
| DIN EN 13975:2003-11 | Identical |
| NS EN 13975 : 1ED 2003 | Identical |
| SN EN 13975 : 2003 | Identical |
| EN 13975:2003 | Identical |
| I.S. EN 13975:2003 | Identical |
| NF EN 13975 : 2003 | Identical |
| BS EN 13975:2003 | Identical |
| NEN EN 13975 : 2003 | Identical |
| NBN EN 13975 : 2003 | Identical |
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