
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
標準編號: AAMI TIR 8 Ed. 1 (1991)
發布時間:1991/7/1 0:00:00
標準類別:Standard
出版單位:Association for Advancement of Medical Instrumentation
標準頁數:21
標準簡介
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.