$74
AAMI/ISO 13408-2:2018
2017
Aseptic processing of health care products – Part 2:Sterilizing filtration
- Format:
- Language(s) :
- Published :
- English
- 11/17/2017
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 selection, set up, validation and routine operation of a sterile-filtration process to be used for aseptic processing of health care products. This document does not apply to removal of mycoplasma or viruses by filtration nor to filtration of whole cell vaccines.
| AAMI/ISO 13408-2:2018 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | AAMI/ISO 13408-2:2018 |
| Scope | Aseptic processing of health care products - Part 2:Sterilizing filtration |
| Publisher | AAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization |
| Languages | English |
| State | |
| Publication Year | 2017 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| ANSI | ANSI Approved |
| File Size | 1 file , 450 KB |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages | 45 |
| Published | 11/17/2017 |
| AAMI/ISO 13408-2:2018 | ||
|---|---|---|
| History | Publisher Year | |
| AAMI/ISO 13408-2:2018 | 2017 | Current |
| AAMI/ISO 13408-2:2003/(R)2013 | 2008 |
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