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      • CAN/CSA-Z11140-1-F07 (C2012)

      Codes & Standards - Purchase

      CAN/CSA-Z11140-1-F07 (C2012)

      Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences générales (norme ISO 11140-1:2005 adoptée, deuxième édition, 2005-07-15)
      SKU: 2418380 Published by CSA Group Publication Year 2007 Reaffirmed in 2012 48 pages Withdrawn

      Product Details

      • Preface/Scope
      Préface

      Ce document constitue la deuxième édition de la CAN/CSA-Z11140-1, Stérilisation des produits de santé - Indicateurs chimiques - Partie 1 : Exigences générales. Il s'agit de l'adoption, sans modifications, de la norme ISO (Organisation internationale de normalisation) 11140-1 (deuxième édition, 2005-07-15) qui porte le même titre. Cette norme remplace l'édition précédente publiée en 1998 qui portait la désignation CAN/CSA-Z11140-1 (norme ISO 11140-1:1995 adoptée).

      Domaine d’application

      1.1
      La présente partie de l'ISO 11140 spécifie les exigences générales et les modes opératoires d'essai relatifs aux indicateurs exposés à des procédés de stérilisation par modification des substances de nature physique et/ou chimique, qui sont utilisés pour contrôler l'acquisition d'un ou plusieurs paramètre(s) requis pour un procédé de stérilisation. Ils ne dépendent pas de leur action en présence ou en l'absence d'un organisme vivant.

      NOTE Les systèmes d'essai biologiques sont considérés comme des essais dont l'interprétation dépend de la démonstration de la viabilité d'un organisme. Des systèmes d'essai de ce type sont traités dans la série de normes ISO 11138 relative aux indicateurs biologiques.

      1.2
      Les exigences et les méthodes d'essai de la présente partie de l'ISO 11140 s'appliquent à tous les indicateurs spécifiés dans les parties suivantes de l'ISO 11140, sauf en cas de modification de l'exigence ou ajout de celle-ci dans une partie suivante, auquel cas l'exigence de cette partie spécifique s'appliquera. L'équipement d'essai concerné est décrit dans l'ISO 18472.

      NOTE Des exigences supplémentaires relatives aux indicateurs d'essai spécifiques (indicateurs de classe 2) sont données dans l'ISO 11140-3, l'ISO 11140-4 et l'ISO 11140-5.
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      GST REG No R119441681
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