Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN ISO 13408-2:2018
• Năm ban hành / Publication date: 2018
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
• Phạm vi áp dụng / Scope of standard: 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.