SS-EN-14136 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

SS-EN-14136 - 2004 EDITION - CURRENT


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This European Standard applies 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). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: -- scheme design and organisation; -- identification of procedures (IVD MDs) used by the participant; -- classification and evaluation of data. NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

To find similar documents by classification:

11.100 (Laboratory medicine)

11.100.10 (In vitro diagnostic test systems)

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Designation Name

SS-EN 14136:2004

Revision Level

2004 EDITION

Status

Current

Publication Date

July 16, 2004

Language(s)

English

Page Count

12

International Equivalent

EN 14136:2004(IDT)