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      • CAN/CSA-Z10651-2-F06 (C2015)

      Codes & Standards - Purchase

      CAN/CSA-Z10651-2-F06 (C2015)

      Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de base et les performances essentielles - Partie 2: Ventilateurs pour soins à domicile pour patients dépendents (norme ISO 10651-2:2004 adoptée, deuxième édition, 2004-07-01, avec exigences propres au Canada)
      SKU: 2417930 Published by CSA Group Publication Year 2006 Reaffirmed in 2015 54 pages Withdrawn

      Product Details

      • Preface/Scope
      Preface

      Ce document constitue la deuxième édition de la CAN/CSA-Z10651-2, Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de base et les performances essentielles - Partie 2 : Ventilateurs pour soins à domicile pour patients dépendants.

      Il s'agit de l'adoption, avec exigences propres au Canada, de la norme ISO (Organisation internationale de normalisation) 10651-2 (deuxième édition, 2004-07-01), qui porte le même titre. Cette norme remplace la première édition publiée en 1999 en anglais seulement qui portait la désignation CAN/CSA-Z10651-2, Ventilateurs pulmonaires à usage médical - Partie 2 : Prescriptions particulières pour ventilateurs pour soins domestiques (norme ISO 10651-2:1996 adoptée).

      Domaine d’application

      Amendement:

      La présente partie de l'ISO 10651 spécifie les exigences relatives aux ventilateurs pulmonaires destinés aux applications à domicile par des patients qui dépendent d'une assistance respiratoire.

      Ces ventilateurs sont considérés comme un équipement vital, sont souvent utilisés dans des endroits où la fiabilité de la puissance motrice n'est pas assurée, et sont fréquemment supervisés par un personnel non médical ayant différents niveaux de formation.

      La présente partie de l'ISO 10651 n'est pas applicable aux ventilateurs de type cuirasse ou «poumon d'acier».

      Les ventilateurs qui sont exclusivement destinés à augmenter la ventilation des patients qui respirent de manière spontanée sont exclus du domaine d'application de la présente partie de l'ISO 10651.

      Les exigences de la présente partie de l'ISO 10651 qui remplacent ou modifient les exigences de la CEI 60601-1:1988 et ses Amendements 1 (1991) et 2 (1995) sont destinées à avoir la priorité sur les exigences générales correspondantes.
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