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SSH EN ISO 13408-2:2011

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

Mar 26, 2012
95.99 Withdrawal of Standard   Dec 22, 2018

General information

95.99     Dec 22, 2018

DPS

DPS/KT 316

European Norm

11.080.01  

English  

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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 directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
90/385/EEC

Active implantable medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SSH EN ISO 13408-2:2011
95.99 Withdrawal of Standard
Dec 22, 2018

REVISED BY

PUBLISHED
SSH EN ISO 13408-2:2018

Related project

Adopted from EN ISO 13408-2:2011