
Microbiological Methods For Gamma Irradiation Sterilization Of Medical Devices
出版:Association for Advancement of Medical Instrumentation

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基本信息
标准编号: AAMI TIR 8 Ed. 1 (1991)
发布时间:1991/7/1 0:00:00
标准类别:Standard
出版单位:Association for Advancement of Medical Instrumentation
标准页数:21
标准简介
Defines proper microbiological procedures for obtaining data necessary to control the production and sterilization of medical devices. Subjects addressed include device sampling, the concept of sample item portion (SIP), media preparation, bioburden methods, validation of bioburden and sterility test methods, and environmental control and monitoring.