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NF 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

12-01-2013

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).

DevelopmentNote
Indice de Classement: S92-035 PR NF EN 14136 June 2001 (05/2001)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Current

Standards Relationship
SN EN 14136 : 2004 Identical
DIN EN 14136:2004-08 Identical
UNI EN 14136 : 2004 Identical
EN 14136:2004 Identical
UNE-EN 14136:2004 Identical
BS EN 14136:2004 Identical

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