NF EN ISO 15193

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

Le présent document définit les exigences relatives au contenu d''une procédure de mesure de référence pour les dispositifs médicaux de diagnostic in vitro et les laboratoires d''analyses de biologie médicale. Il peut être appliqué par toute personne, tout organisme ou toute institution impliqué(e) dans l''une des branches de la biologie médicale afin de rédiger un document qui servira de mesure de référence. Il vient à l''appui des exigences essentielles de la Directive 98/79/CE sur les Dispositifs médicaux de diagnostic in vitro.

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