NF EN ISO 11737-1

Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products

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. Il 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. Il ne s''applique pas non plus à la surveillance microbiologique de l''environnement dans lequel sont fabriqués les produits de santé.

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