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PREN 13975 : DRAFT 2002

PREN 13975 : DRAFT 2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SAMPLING PROCEDURES USED FOR ACCEPTANCE TESTING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES - STATISTICAL ASPECTS

Superseded date

03-01-2003

Published date

01-12-2013

Publisher

Comite Europeen de Normalisation

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Superseded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

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