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ISO 13408-2:2018

Current
Current

The latest, up-to-date edition.

Aseptic processing of health care products — Part 2: Sterilizing filtration
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

09-01-2018

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.

Committee
ISO/TC 198
DevelopmentNote
Supersedes ISO/DIS 13408-2. (01/2018)
DocumentType
Standard
Pages
35
PublisherName
International Organization for Standardization
Status
Current
Supersedes

ISO 13408-4:2005 Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13408-3:2006 Aseptic processing of health care products Part 3: Lyophilization
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems

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