PREN 13975 : DRAFT 2002
Superseded
Superseded
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SAMPLING PROCEDURES USED FOR ACCEPTANCE TESTING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES - STATISTICAL ASPECTS
Published date
01-12-2013
Publisher
Superseded date
03-01-2003
Superseded by
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Procedures
Annex A (informative) General notes
Defines sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body. Also defines requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products.
| Committee |
TC 140
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| 00/564528 DC : DRAFT SEP 2000 | Identical |
Summarise
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