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    • CAN/CSA-Z11135-2-F09 (C2014)

    Codes & Standards - Purchase

    CAN/CSA-Z11135-2-F09 (C2014)

    Stérilisation des produits de santé - Oxyde d'éthylène - Partie 2: Directives relatives à l'application de l'ISO 11135-1 (norme ISO/TS 11135-2:2008 adoptée, première édition, 2008-08-01)
    SKU: 2419584 Published by CSA Group Publication Year 2009 Reaffirmed in 2014 60 pages Withdrawn

    Product Details

    • Preface/Scope
    Preface
    Ce document constitue la première édition de la CAN/CSA-Z11135-2, Stérilisation des produits de santé - Oxyde d'éthylène -Partie 2 : Directives relatives à l'application de l'ISO 11135-1. Il s'agit de l'adoption, sans modifications, de la Spécification technique ISO (Organisation internationale de normalisation) 11135-2 (première édition, 2008-08-01), qui porte le même titre.

    Domaine d’application

    La présente Spécification technique présente les mêmes exclusions que l'ISO 11135-1.

    Afin de simplifier l'utilisation des renvois, la numérotation des articles dans la présente Spécification technique est identique à celle de l'ISO 11135-1. L'ISO 11135-1:2007, Annexe C, contient d'autres directives permettant de satisfaire aux exigences de l'ISO 11135-1, qu'il convient d'utiliser conjointement à la présente Spécification technique. Les directives données dans la présente Spécification technique peuvent être utilisées par des personnes ayant une maîtrise de base des principes de la stérilisation à l'oxyde d'éthylène, mais susceptibles d'avoir, besoin d'aide pour déterminer le meilleur moyen de répondre aux exigences de l'ISO 11135-1. La présente Spécification technique n'est pas destinée aux personnes n'ayant aucune connaissance des principes de la stérilisation à l'oxyde d'éthylène.
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