AAMI ISO TIR 13409:1996被替代
Sterilization Of Health Care Products - Radiation Sterilization - Substantiation Of 25 Kgy As A Sterilization Dose For Small Or Infrequent Production Batches
出版：Association for Advancement of Medical Instrumentation
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基本信息
标准编号： AAMI ISO TIR 13409:1996
标准类别：Standard
出版单位：Association for Advancement of Medical Instrumentation
标准页数：15
标准简介
Describes 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 1,000 colony forming units (cfu) that are manufactured in small quantities (less than 1,000 product units).
标准备注
Together with AAMI ISO 11137, supersedes AAMI ST32. (04/2004)
本标准替代的旧标准
替代本标准的新标准
等同采用的国际标准
ISO/TS 13409:2002 - Identical
