ISO 13408-2:2018
Current
The latest, up-to-date edition.
Aseptic processing of health care products — Part 2: Sterilizing filtration
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French, English
09-01-2018
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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.
ISO 13408-2:2018 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).
ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters.
ISO 13408-2:2018 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.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 13408-2. (01/2018)
|
| DocumentType |
Standard
|
| Pages |
35
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| PN-EN ISO 13408-2:2018-05 | Identical |
| DIN EN ISO 13408-2:2018-06 | Identical |
| NEN-EN-ISO 13408-2:2018 | Identical |
| UNI EN ISO 13408-2:2018 | Identical |
| I.S. EN ISO 13408-2:2018 | Identical |
| EN ISO 13408-2:2018 | Identical |
| ONORM EN ISO 13408-2:2018 | Identical |
| I.S. EN ISO 13408-2:2011 | Identical |
| SS-EN ISO 13408-2:2018 | Identical |
| SN EN ISO 13408-2:2018 | Identical |
| BS EN ISO 13408-2:2011 | Identical |
| NF EN ISO 13408-2 : 2018 | Identical |
| IS/ISO 13408 : Part 2 : 2018 | Identical |
| ANSI/AAMI/ISO 13408-2:2018 | Identical |
| BS EN ISO 13408-2:2018 | Identical |
| UNE-EN ISO 13408-2:2018 | Identical |
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| ISO 13408-7:2012 | Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13408-3:2006 | Aseptic processing of health care products Part 3: Lyophilization |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 13408-6:2005 | Aseptic processing of health care products Part 6: Isolator systems |
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