NF EN 14136

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

Le présent document s'applique aux programmes d'évaluation externe de la qualité, qui incluent dans leurs fonctions l'évaluation de la performance de procédures spécifiées de diagnostic in vitro (y compris les dispositifs médicaux de diagnostic in vitro). Il établit les exigences nécessaires pour permettre de remplir cette fonction, relatives à la conception et l'organisation du programme, l'identification des procédures utilisées par le participant, et la classification et l'évaluation des données.

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