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ISO 11138-2:2006
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Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes

This standard was last reviewed* in 2009.

*ISO standards are reviewed every five years.

Abstract

ISO 11138-2:2006 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.

 

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