NF EN 13641

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Le présent document spécifie les exigences relatives à la conception et la fabrication des réactifs de diagnostic in vitro, y compris les produits réactifs, étalons, matériaux de contrôle et trousses de réactifs, appelés dans le présent document réactifs DIV, afin de maîtriser le risque d'infection.

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