ISO 13408-2-2003 医疗保健产品的无菌加工.第2部分:过滤

标准号：ISO 13408-2-2003
中文标准名称：医疗保健产品的无菌加工.第2部分:过滤
英文标准名称：Aseptic processing of health care products - Part 2: Filtration
标准类型：C50
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C50
国际标准分类号：11.080.01;11.120.01
适用范围：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).