CSA ISO 11737-1:F19:2019 Edition
$44.85
Stérilisation des produits de santé — Méthodes microbiologiques — Partie 1 : Détermination d’une population de microorganismes sur des produits
| Published By | Publication Date | Number of Pages |
| CSA | 2019 | 76 |
Préface CSA
Ce document constitue la première édition de CSA ISO 11737-1, Stérilisation des produits de santé — Méthodes microbiologiques — Partie 1 : Détermination d'une population de microorganismes sur des produits. Il s’agit de l’adoption, sans modifications, de la norme ISO (Organisation internationale de normalisation) 11737-1 (troisième édition, 2018-01), qui porte le même titre.
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 et fournit des recommandations relatives au dénombrement et à la caractérisation microbienne de la population de microorganismes viables sur ou dans un produit de santé, un composant, une matière première ou un emballage.
NOTE 1 La nature et l'étendue de la caractérisation microbienne dépendent de l'utilisation prévue des données de biocharge.
NOTE 2 Voir les recommandations relatives aux Articles 1 à 9 dans l’Annexe A.
Le présent document ne s'applique pas au dénombrement ni à l'identification des virus, prions ou protozoaires. Cette exclusion englobe l’élimination et la détection des agents responsables des encéphalopathies spongiformes, telles que la tremblante du mouton, l'encéphalopathie spongiforme bovine ou la maladie de Creutzfeldt-Jakob.
NOTE 3 L’ISO 22442-3, l'ICH Q5A(R1) et l’ISO 13022 contiennent des recommandations relatives à l’inactivation des virus et des prions.
Le présent document ne s'applique pas à la surveillance microbiologique de l'environnement dans lequel sont fabriqués les produits de santé.
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