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Specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
Author | ANSI/AAMI/ISO |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2014-10-13 |
ICS | 07.100.10 : Medical microbiology 11.080.01 : Sterilization and disinfection in general |
Replace | ANSI/AAMI/ISO 11737-2 (1998) |
Cross references | ISO 11737-2 (2009-11), IDT |
Year | 2009 |
Document history | ANSI/AAMI/ISO 11737-2 (2009) |
Country | USA |
Keyword | ANSI 11737;ANSI/AAMI/ISO 11737;11737;ANSI/AAMI/ISO 11737-2-2009 (R2014) |