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AAMI/ISO 13408-2:2018
Aseptic processing of health care products - Part 2: Sterilizing filtrationMore info
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.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2018-02-01 |
| ICS | 11.080.01 : Sterilization and disinfection in general |
| Replace | ANSI/AAMI/ISO 13408-2 (2003) |
| Cross references | ISO 13408-2 (2018-01), IDT |
| Year | 2018 |
| Document history | ANSI/AAMI/ISO 13408-2 (2018) |
| Country | USA |
| Keyword | ANSI 13408;ANSI/AAMI/ISO 13408;13408;ANSI/AAMI/ISO 13408-2-2018 |