Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAM 1:2025); German and English version EN ISO 13408-2:2018/prA1:2025
Abstract
This part of ISO 13408 specifies the requirement for sterile filtration performed in accordance with ISO 13408-1 as part of the aseptic manufacturing of healthcare products. It also provides guidance for filter users on the general requirements for the establishment, validation and routine operation of a sterile filtration process. This part of ISO 13408 does not apply to the removal of viruses. Sterile filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. whole-cell bacterial inoculants). This part of ISO 13408 does not apply to HEPA filters. This standard does not specify requirements for the development, validation and routine control of a process for the removal of the agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. In certain countries, specific recommendations have been developed for the processing of materials that may be contaminated with these pathogens. This is an amendment 1 to the standard.
Begin
2024-07-30
WI
00204095
Planned document number
DIN EN ISO 13408-2/A1
Project number
17600114
Responsible national committee
NA 176-03-10 AA - Aseptic processing
Responsible european committee
CEN/TC 204 - Sterilization of medical devices
Responsible international committee
ISO/TC 198/WG 9 - Aseptic processing
draft standard
Aseptic processing of health care products - Part 2: Sterilizing filtration - Amendment 1 (ISO 13408-2:2018/DAM 1:2025); German and English version EN ISO 13408-2:2018/prA1:2025
2025-11
Order from DIN Media
