Standard

SN EN ISO 13408-2:2011

Sep 2011 Withdrawn

Note: Latest version: SN EN ISO 13408-2:2018

Existing or new amendments and versions must be purchased separately.

Language English French German

Services Online + Pdf CHF 73.00 Online CHF 63.00

There are no extended editions available for this standard

There are no available corrigendum or amendments for this standard. Any future corrigendum and amendments will be added automatically for subscribers.

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).

Products specifications

Standard from INB
Published: September 1 2011
Withdrawn: September 1 2018
Effective: September 1 2011
Document type: EN
Pages
ISBN:

ICS: 11.080.01
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 171

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: 98/79/EG

Product Relations

Replaced by: SN EN ISO 13408-2:2018
Replaces: SN EN 13824:2005
Adopted from: ISO 13408-2:2003, IDT

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (0)

Version history History (3)

SN EN ISO 13408-2:2018