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ISO 13408-2:2003

Aseptic processing of health care products — Part 2: Filtration

Mar 26, 2003
95.99 Withdrawal of Standard   Jan 9, 2018

General information

95.99     Jan 9, 2018

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

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Scope

ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.
ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

Life cycle

NOW

WITHDRAWN
ISO 13408-2:2003
95.99 Withdrawal of Standard
Jan 9, 2018

REVISED BY

PUBLISHED
ISO 13408-2:2018