Status : Withdrawn

This standard has been revised by ISO 13408-2:2018

Abstract

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     : Withdrawn
    Publication date
     : 2003-03
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 11
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
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