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  • BSI
    BS EN ISO 13408-2:2018 Aseptic processing of health care products - Sterilizing filtration
    Edition: 2018
    $418.55
    / user per year

Description of BS EN ISO 13408-2:2018 2018

This document specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.

This document is not applicable to removal of viruses.

Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines).

This document is not applicable to high efficiency particulate air (HEPA) filters.

This document does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.



Standard NumberBS EN ISO 13408-2:2018
TitleAseptic processing of health care products - Sterilizing filtration
StatusConfirmed
Publication Date2018-04-10
ReplacesBS EN ISO 13408-2:2011
Identical National Standard OfEN ISO 13408-2:2018, ISO 13408-2:2018
DescriptorsQuality management, Sterilization (hygiene), Production, Sterile equipment, Filters, Filtration, Verification, Medical equipment, Biological filters, Environment (working), Personnel, Quality assurance systems, Quality control
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 580 86866 5
PublisherBSI
Pages44

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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