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NEN NPR ISO/TS 13409:2002现行

Sterilization Of Health Care Products - Radiation Sterilization - Substantiation Of 25 Kgy As A Sterilization Dose For Small Or Infrequent Production Batches

出版:Nederlands Normalisatie Instituut

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基本信息
标准编号: NEN NPR ISO/TS 13409:2002
标准类别:Standard
出版单位:Nederlands Normalisatie Instituut
标准页数:0
标准简介

Defines a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1000 colony-forming units (cfu) that are manufactured in small quantities (less than 1000 product units).

等同采用的国际标准

ISO/TS 13409:2002 - Identical