Préface CSA Ce document constitue la deuxième édition de CSA ISO 11607-2, Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : Exigences de validation pour les procédés de formage, scellage et assemblage . Il s’agit de l’adoption, sans modification, de la norme ISO (Organisation internationale de normalisation) 11607-2 (deuxième édition, 2019-02), qui porte le même titre. Il remplace l’édition antérieure publiée en 2016 qui portait la désignation CAN/CSA-ISO 11607-2 (norme ISO 11607-2:2006 adoptée, y compris l’amendement 1:2014). Le Groupe CSA tient à souligner que l’élaboration de cette norme a été rendue possible, en partie, par le soutien financier des gouvernements de l’Alberta, de la Colombie-Britannique, du Manitoba, du Nouveau-Brunswick, de Terre-Neuve-et-Labrador, des Territoires du Nord-Ouest, de la Nouvelle-Écosse, du Nunavut, de l’Ontario, de l’Île-du-Prince-Édouard, du Québec, de la Saskatchewan et du Yukon, tel qu’administré par l’Agence canadienne des médicaments et des technologies de la santé (ACMTS). Cette norme a été élaborée conformément aux exigences du Conseil canadien des normes concernant les Normes nationales du Canada. Cette norme a été publiée en tant que Norme nationale du Canada par Groupe CSA. Domaine d’application Le présent document spécifie les exigences pour la mise au point et la validation des procédés d’emballage de dispositifs médicaux qui sont stérilisés au stade terminal. Ces procédés comprennent le formage, le scellage et l’assemblage de systèmes de barrière stérile préformés, de systèmes de barrière stérile et de systèmes d’emballage. Il s’applique à l’industrie, aux établissements de santé et à tout lieu où les dispositifs médicaux sont emballés et stérilisés. Il ne couvre pas toutes les exigences relatives à l’emballage des dispositifs médicaux fabriqués de manière aseptique. Des exigences supplémentaires peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.
| SDO | CSA: Canadian Standards Association |
| Document Number | |
| Publication Date | May 6, 2021 |
| Language | fr - French |
| Page Count | |
| Revision Level | |
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