Standard

ISO 13408-2:2003

Mar 2003 Withdrawn

Note: Latest version: ISO 13408-2:2018

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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).

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Standard from ISO
Published: March 26 2003
Withdrawn: January 9 2018
Period for objection until: July 2 2001
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.080.01
International TC: ISO/TC 198

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Revised by: ISO 13408-2:2018
Adopted by: SN EN ISO 13408-2:2011
Adopted by: NF EN ISO 13408-2:2011

ISO 13408-2:2003

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ISO 13408-2:2018

ISO 13408-2:2003

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ISO 13408-2:2018

ISO 13408-2:2003

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