ISO 13408-2:2003
ISO 13408-2:2003


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 

  •  :  Withdrawn
     : 2003-03
  •  : 1
     : 11
  •  : ISO/TC 198 Sterilization of health care products
  •  :
    11.080.01 Sterilization and disinfection in general

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