SS-EN-14136 › Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
SS-EN-14136
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2004 EDITION
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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:
11.100.10 (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)