SN EN 13975 : 2003
Current
The latest, up-to-date edition.
SAMPLING PROCEDURES USED FOR ACCEPTANCE TESTING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES - STATISTICAL ASPECTS
12-01-2013
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.
| DocumentType |
Standard
|
| PublisherName |
Swiss Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN 13975 : 2003 | Identical |
| EN 13975:2003 | Identical |
| BS EN 13975:2003 | Identical |
| DIN EN 13975:2003-11 | Identical |
| UNE-EN 13975:2003 | Identical |
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