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AAMI/ISO 11138-2:2017

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AAMI/ISO 11138-2:2017

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

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Provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

Author ANSI/AAMI/ISO
Editor AAMI
Document type Standard
Format File
Confirmation date 2017-08-01
ICS 11.080.01 : Sterilization and disinfection in general
11.080.20 : Disinfectants and antiseptics
Replace ANSI/AAMI/ISO 11138-2 (2006)
Cross references ISO 11138-2 (2017-03), IDT
Year 2017
Document history ANSI/AAMI/ISO 11138-2 (2017)
Country USA
Keyword ANSI 11138;ANSI/AAMI/ISO 11138;11138;ANSI/AAMI/ISO 11138-2-2017