標準號：ISO 13408-2-2003
中文標準名稱：醫療保健產品的無菌加工.第2部分:過濾
英文標準名稱：Aseptic processing of health care products - Part 2: Filtration
標準類型：C50
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C50
國際標準分類號：11.080.01;11.120.01
適用范圍：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).