99.60 Withdrawal effective Mar 21, 2018
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
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).
Legislation related to this standard
WITHDRAWN
EN 13824:2004
WITHDRAWN
EN ISO 13408-2:2011
99.60
Withdrawal effective
Mar 21, 2018
PUBLISHED
EN ISO 13408-2:2018