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UNI EN 14136 : 2004

Current

Current

The latest, up-to-date edition.

USE OF EXTERNAL QUALITY ASSESSMENT SCHEMES IN THE ASSESSMENT OF THE PERFORMANCE OF IN VITRO DIAGNOSTIC EXAMINATION PROCEDURES

Published date

01-10-2004

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design requirements for EQAS
5 Requirements for organisations conducting EQAS
6 Assessment of analytical examination procedures
7 Using results to identify possible deficiencies
8 Archiving documents
9 Confidentiality
Annex ZA (informative) Clauses of this European Standard
                       addressing essential requirements
                       or other provisions of EU Directives
Bibliography

Applicable to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs).

Committee
CT 44
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current

Standards Relationship
UNE-EN 14136:2004 Identical
I.S. EN 14136:2004 Identical
NS EN 14136 : 1ED 2004 Identical
NBN EN 14136 : 2004 Identical
NF EN 14136 : 2004 Identical
BS EN 14136:2004 Identical
NEN EN 14136 : 2004 Identical
SN EN 14136 : 2004 Identical
EN 14136:2004 Identical
DIN EN 14136:2004-08 Identical

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