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I.S. EN 13975:2003

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2003

Preview

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
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
Pages
14
PublisherName
National Standards Authority of Ireland
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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$66.40
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