CAN/CSA-ISO 11663:F15:2015 Edition
$28.60
Qualité des fluides de dialyse pour hémodialyse et thérapies apparentées
| Published By | Publication Date | Number of Pages |
| CSA | 2015 | 33 |
Préface CSA
Ce document constitue la deuxième édition de la CAN/CSA-ISO 11663, Qualité des fluides de dialyse pour hémodialyse et thérapies apparentées. Ils s’agit de l’adoption, sans modifications, de la norme ISO (Organisation internationale de normalisation) 11663 (deuxième édition, 2014-04-01) qui porte le même titre. Cette norme remplace l’édition antérieure publiée en 2011 qui portait la désignation CAN/CSA-ISO 11663 (norme ISO 11663:2009 adoptée).
Domaine d’application
La présente Norme internationale spécifie des exigences de qualité minimales pour les fluides de dialyse dans le cadre d’hémodialyses et de thérapies apparentées.
Elle inclut les fluides de dialyse utilisés pour l’hémodialyse et l’hémofiltration, notamment le fluide de substitution pour hémodiafiltration et hémofiltration.
Elle n’aborde pas les exigences relatives à l’eau et aux concentrés utilisés pour préparer le fluide de dialyse ou l’équipement utilisé lors de sa préparation. Ces domaines sont traités par d’autres Normes internationales.
Les systèmes de régénération des fluides de dialyse à base de sorbant qui régénèrent et remettent en circulation de petits volumes de fluide de dialyse, les systèmes pour traitements continus de suppléance rénale qui utilisent des solutions préemballées et les systèmes et solutions pour dialyse péritonéale sont exclus de la présente Norme internationale.
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