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
EN 14136:2004 history
2004EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures