Standard

NS-EN ISO 13408-2:2011

Sept 2011 Withdrawn

Note: This standard has a new edition: NS-EN ISO 13408-2:2018

Corrigendums and amendments are bought separately.

Language English

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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).

Document information

Standard from SN
Published: 1 September 2011
Withdrawn: 1 June 2018
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 90/385/EEC, 93/42/EEC, 98/79/EC

Product Relations

Replaced by: NS-EN ISO 13408-2:2018
Replaces: NS-EN 13824:2004
Adopted from: EN ISO 13408-2:2011 , 0

Product life cycle

Previous product

Withdrawn

NS-EN 13824:2004
Current product

Withdrawn

NS-EN ISO 13408-2:2011
Replaced by

Published

NS-EN ISO 13408-2:2018

NS-EN ISO 13408-2:2011

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NS-EN ISO 13408-2:2018