AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 : R201300现行
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS
出版：Association for the Advancement of Medical Instrumentation
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基本信息
标准编号： AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013 : R201300
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 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.
等同采用的国际标准
ISO 13408-6 : 2005(R2014) - Identical
