ISO 13408-2:2003 健康护理产品无菌处理-第2部分：筛选

标准编号：ISO 13408-2:2003

中文名称：健康护理产品无菌处理-第2部分：筛选

英文名称：Aseptic processing of health care products — Part 2: Filtration

发布日期：2003-03

标准范围

ISO 13408-2:2003规定了作为医疗保健产品无菌处理一部分的过滤消毒要求。它还为过滤用户提供了有关用于医疗保健产品无菌处理的灭菌过滤过程的设置、验证和日常操作的一般要求的指导。ISO 13408-2:2003不适用于去除病毒。灭菌过滤不适用于含有颗粒作为有效成分的液体，其有效成分大于过滤器的孔径（例如细菌全细胞疫苗）。

ISO 13408-2:2003 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.ISO 13408-2:2003 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).

标准预览图