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AAMI TIR 8 : 1ED 91被替代
MICROBIOLOGICAL METHODS FOR GAMMA IRRADIATION STERILIZATION OF MEDICAL DEVICES
出版：Association for the Advancement of Medical Instrumentation
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標(biāo)準(zhǔn)編號(hào)： AAMI TIR 8 : 1ED 91
標(biāo)準(zhǔn)類別：Standard
出版單位：Association for the Advancement of Medical Instrumentation
標(biāo)準(zhǔn)頁(yè)數(shù)：0
標(biāo)準(zhǔn)簡(jiǎn)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.
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