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    • CAN/CSA-ISO 10993-1-F01

    Codes & Standards - Purchase

    CAN/CSA-ISO 10993-1-F01

    Évaluation biologique des dispositifs médicaux - Partie 1: Evaluation et essais (norme ISO 10993-1:1997 adoptée, deuxième édition, 1997-12-15)
    SKU: 2415361 Published by CSA Group Publication Year 2001 14 pages Withdrawn

    Product Details

    • Preface/Scope
    1 Domaine d'application

    La présente partie de l'ISO 10993 décrit

    a) les principes généraux sur lesquels repose l'évaluation biologique des dispositifs médicaux;
    b) la classification de dispositifs, basée sur la nature et la durée de leur contact avec le corps humain;
    c) le choix des essais appropriés

    La présente partie de l'ISO 10993 ne traite pas de l'essai des matériaux et dispositifs qui n'entrent pas directement ou indirectement en contact avec le corps du patient.  Elle n'aborde pas non plus les risques biologiques dus aux défaillances mécaniques. Les autres parties de l'ISO 10993 concernent des essais spécifiques comme indiqués dans l'avant-propos (voir également les justificatifs en A.2).
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