AAMI ISO 13408-6:2005现行
Aseptic Processing Of Health Care Products - Part 6: Isolator Systems
出版：Association for Advancement of Medical Instrumentation
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基本信息
标准编号： AAMI ISO 13408-6:2005
标准类别：Standard
出版单位：Association for Advancement of Medical Instrumentation
标准页数：44
标准简介
Describes the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
本标准替代的旧标准
等同采用的国际标准
ISO 13408-6 : 2005(R2014) - Identical
