BS EN ISO 13408-2:2018 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.
Cross References:ISO 13408-1:2008
ISO 13408-1:2008/AMD 1:2013
ISO 13485
ISO 11135
ISO 11139
ISO 11137-1
ISO 13408-4
ISO 17665-1
ISO 13408-5
ISO/IEC 90003
ISO 13408-6
ISO 11737-1
ISO 13408-3
ISO 13408-7
ISO 10993-12:2012
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 1.2 MB |
| ISBN(s) : | 9780580868665 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 42 |
| Product Code(s) : | 30302490, 30302490, 30302490 |
| Published : | 04/10/2018 |
| Same As : | BS EN ISO 13408-2:2018 |
