Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

12-10-2004

Publisher

Asociacion Espanola de Normalizacion

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	CTN 129
DocumentType	Standard
Pages	16
PublisherName	Asociacion Espanola de Normalizacion
Status	Current

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