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ANSI/AAMI/ISO 11135:2014

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ANSI/AAMI/ISO 11135:2014

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

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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