标准摘要
[中文适用范围]： 本文件规定了灭菌过滤作为医疗产品无菌处理的一部分的要求。这些活动应根据 ISO 13408-1 进行。 它还为滤器用户提供关于灭菌过滤工艺的设置、验证和常规运行的一般要求提供指导。 本文件不适用于去除病毒。 对于故意含有大于滤过器孔径的颗粒（例如细菌全细胞疫苗）的液体，灭菌过滤不适用。 本文件不适用于高效粒径空气 (HEPA) 过滤器。 [外文原描述]： ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. ISO 13408-2:2018 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines). ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters. ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
英文名称Aseptic processing of health care products — Part 2: Sterilizing filtration