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ISO 13408-2:2003

Aseptic processing of health care products — Part 2: Filtration

Standard Details

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).

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO 13408-2:2003
Document Year: 2003
Pages: 11
Edition: 1
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products
  • ICS:
  • 11.080.01 Sterilization and disinfection in general

Life Cycle

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WITHDRAWN
ISO 13408-2:2003
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