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Specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
Author | ANSI/AAMI/ISO |
---|---|
Editor | AAMI |
Document type | Standard |
Format | File |
Confirmation date | 2015-07-27 |
ICS | 11.080.01 : Sterilization and disinfection in general |
Replace | ANSI/AAMI/ISO 11135-1 (2007) |
Cross references | ISO 11135 (2014-07), IDT |
Year | 2015 |
Document history | ANSI/AAMI/ISO 11135 (2015) |
Country | USA |
Keyword | ANSI 11135;11135;ANSI/AAMI/ISO 11135-2015 |