Reference number
ISO 13408-2:2003
© ISO 2024
ISO 13408-2:2003
Aseptic processing of health care products — Part 2: Filtration
Edition 1
2003-03
Retirada
Retirada (Edición 1, 2003)

Resumen

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).

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 2003-03
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 1
    Número de páginas
     : 11
  • Comité Técnico :
    ISO/TC 198
    ICS :
    11.080.01 
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