ISO 13408-2:2018规定了作为按照ISO 13408-1进行的医疗保健产品无菌处理一部分的消毒过滤要求。它还为过滤用户提供了有关灭菌过滤过程的设置、验证和常规操作的一般要求的指导。 ISO 13408-2:2018不适用于去除病毒。 灭菌过滤不适用于故意含有大于过滤器孔径的颗粒的液体（例如细菌全细胞疫苗）。 ISO 13408-2:2018不适用于高效微粒空气（HEPA）过滤器。 ISO 13408-2:2018未规定清除海绵状脑病病原体（如羊瘙痒病、牛海绵状脑病和克雅氏病）过程的开发、验证和常规控制要求。对于可能被这些制剂污染的材料的处理，特定国家已经提出了具体的建议。

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.