ANSI/AAMI/ISO 13408-6-2005 标准详情
- 标准号:ANSI/AAMI/ISO 13408-6-2005
- 中文标题:保健产品的无菌加工.第6部分:隔离器系统
- 英文标题:Aseptic Processing of health care products - Part 6: Isolator systems
- 标准类别:美国国家标准
- 发布日期:2005
Specifies 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. This sta
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