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    • CAN/CSA-ISO 10993.7-F98 (C2009)

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    CAN/CSA-ISO 10993.7-F98 (C2009)

    Évaluation biologique des dispositifs médicaux - Partie 7: Résidus de stérilisation à l'oxyde d'éthylène (norme ISO 10993- 7:1995 adoptée)
    SKU: 2410865 Published by CSA Group Publication Year 1998 Reaffirmed in 2009 59 pages Withdrawn

    Product Details

    • Preface/Scope
    Domaine d'application

    La présente partie de l'ISO 10993 prescrit les limites admissibles des résidus d'oxyde d'éthylène et de chlorhydrate d'éthylène pour des dispositifs médicaux individuels stérilisés à l'oxyde d'éthylène, les modes opératoires de mesure de l'oxyde d'éthylène et du chlorhydrate d'éthylène et les méthodes de détermination de la conformité des dispositifs en vue de leur commercialisation. Une documentation supplémentaire et les lignes directrices sont également incluses dans les annexes informatives.

    Les dispositifs médicaux stérilisés à l'oxyde d'éthylène et ne présentant pas de contact avec le patient (dispositif de diagnostic in vitro) ne sont pas couverts par la présente Norme internationale.

     
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