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ISO 13408-2:2018

Aseptic processing of health care products — Part 2: Sterilizing filtration

Jan 9, 2018

General information

90.93     Jan 31, 2024

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

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Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 13408-2:2003

NOW

PUBLISHED
ISO 13408-2:2018
90.93 Standard confirmed
Jan 31, 2024

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
ISO 13408-2:2018/AWI Amd 1

National adoptions

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

60.60 Standard published

DPS/KT 316 more