NF EN ISO 11137-2

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Le présent document spécifie des méthodes de détermination de la dose minimale nécessaire pour satisfaire à une exigence spécifiée de stérilité, ainsi que des méthodes pour justifier l''utilisation de la dose stérilisante de 25 kGy ou 15 kGy, pour obtenir un niveau d''assurance de la stérilité (NAS) de 10?6. Il spécifie également des méthodes d''audit de la dose stérilisante utilisées pour démontrer l''efficacité continue de la dose stérilisante. Il définit des familles de produits pour l''établissement de la dose stérilisante et l''audit de la dose stérilisante. Il vient à l''appui des exigences essentielles des Directives UE 90/385/CEE, 93/42/CEE et 98/79/CE relativent aux dispositifs médicaux.

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