AAMI ANSI/AAMI/ISO 11138-2:2017/(R)2024

Current Revision
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes

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AAMI ANSI/AAMI/ISO 11138-2:2017/(R)2024

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

PUBLISH DATE 2024
AAMI ANSI/AAMI/ISO 11138-2:2017/(R)2024
This document specifies 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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