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AAMI/ISO 13408-6:2005 (R2013)
Aseptic processing of health care products - Part 6: Isolator systemsMore info
Specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. The document focuses on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2013-11-26 |
| ICS | 11.080.01 : Sterilization and disinfection in general |
| Cross references | ISO 13408-6 (2005-06), IDT |
| Modified by | ANSI/AAMI/ISO 13408-6/A1 (2013) |
| Year | 2005 |
| Document history | |
| Country | USA |
| Keyword | ANSI 13408;ANSI/AAMI/ISO 13408;13408;ANSI/AAMI/ISO 13408-6-2005 (R2013) |