Tiêu chuẩn quốc tế
Số hiệu
Standard Number
EN ISO 13408-2:2011
Năm ban hành 2011
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
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Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard This part of ISO 13408 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. This part of ISO 13408 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).
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