AAMI ISO TIR 13409 : 1996 ERRATA 2005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 the Advancement of Medical Instrumentation
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基本信息
标准编号： AAMI ISO TIR 13409 : 1996 ERRATA 2005
标准类别：Standard
出版单位：Association for the Advancement of Medical Instrumentation
标准页数：0
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).
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