$97
ISO 13408-2:2018
2018
Aseptic processing of health care products – Part 2: Sterilizing filtration
- Format:
- Language(s) :
- Published :
- English
- 01/01/2018
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.
| ISO 13408-2:2018 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | ISO 13408-2:2018 |
| Scope | Aseptic processing of health care products - Part 2: Sterilizing filtration |
| Publisher | ISO - International Organization for Standardization |
| Languages | English |
| State | |
| Publication Year | 2018 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| Edition | 2nd |
| File Size | 1 file , 930 KB |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages | 42 |
| Published | 01/01/2018 |
| Same As | ISO 13408-2:2018 |
| ISO 13408-2:2018 | ||
|---|---|---|
| History | Publisher Year | |
| ISO 13408-2:2018 | 2018 | Current |
| ISO 13408-2:2003 | 2003 |
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