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    • CAN/CSA-ISO 10993.11-F98 (C2002)

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    CAN/CSA-ISO 10993.11-F98 (C2002)

    Évaluation biologique des dispositifs médicaux - Partie 11: Essais de toxicité systémique (norme ISO 10993-11:1993 adoptée)
    SKU: 2410868 Published by CSA Group Publication Year 1998 Reaffirmed in 2002 8 pages Withdrawn

    Product Details

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    Domaine d'application

    La présente partie de l'ISO 10993 fixe des méthodes d'évaluation du potentiel de toxicité systémique des dispositifs médicaux susceptibles de relarguer des constituants dans le corps. Elle comporte, en outre, des essais de pyrogénicité.

    Les méthodes d'essai citées dans la présente partie de l'ISO 10993 sont issues de Normes internationales, de normes nationales, de directives et de réglementations. La présente partie de l'ISO 10993 concerne le produit proprement dit et/ou les substances relargables. Il est prévu que les essais intéressant les extraits ou les substances relargables soient effectués en choisissant des véhicules d'extraction appropriés pe rmettant une extraction maximale de substances relargables, afin d'effectuer les essais biologiques.
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