NF EN 12287
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
Le présent document spécifie les prescriptions et les présentations requises pour la description des matériaux de référence. Il ne traite pas de la fabrication des matériaux de référence.
Le présent document spécifie les prescriptions et les présentations requises pour la description des matériaux de référence. Il ne traite pas de la fabrication des matériaux de référence.
Le présent document spécifie des exigences concernant les matériaux de référence certifiés et le contenu de la documentation associée afin qu''ils soient considérés comme étant de niveau métrologique supérieur 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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