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EVS-EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

General information

Withdrawn from 02.04.2018
Base Documents
ISO 13408-2:2003; EN ISO 13408-2:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.04.2018
Main
03.08.2011
Main
Main
EVS-EN 13824:2005
This part of ISO 13408 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. This part of ISO 13408 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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