ISO-13408-2 › Historical Revision Information
Part 2: Filtration, Aseptic Processing of Health Care Products

ISO-13408-2 - 1ST EDITION - SUPERSEDED
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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).

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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 13408-2:2003

Revision Level

1ST EDITION

Status

Superseded

Publication Date

March 15, 2003

Committee Number

ISO/TC 198