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EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) EN ISO 13408-2:2011

Publication date:   Aug 17, 2011

General information

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

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Scope

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).

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
more
93/42/EEC

Medical devices

Harmonized/Supporting
more
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
more

Life cycle

PREVIOUSLY

WITHDRAWN
EN 13824:2004

NOW

WITHDRAWN
EN ISO 13408-2:2011
99.60 Withdrawal effective
Mar 21, 2018

REVISED BY

PUBLISHED
EN ISO 13408-2:2018

Relations

Adopted from ISO 13408-2:2003 IDENTICAL