Standard Swedish standard · SS-EN ISO 13408-2:2011

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

Status: Withdrawn

· Replaced by: SS-EN ISO 13408-2:2018
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Standard Swedish standard · SS-EN ISO 13408-2:2011

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

Subjects

Sterilization and disinfection in general (11.080.01) General (11.120.01)


Buy this standard

Standard Swedish standard · SS-EN ISO 13408-2:2011

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
Subscribe on standards - Read more Dölj
Price: 875 SEK
standard ikon pdf

PDF

Price: 875 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: SIS

International title:

Article no: STD-80776

Edition: 1

Approved: 7/12/2011

No of pages: 28

Replaces: SS-EN 13824:2005

Replaced by: SS-EN ISO 13408-2:2018