In ISO 11138-1, Part 2 covers Biological indicators for ethylene oxide sterilization processes. As stated under the scope of this section, “This part of ISO 11138 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.”
If you choose to not use Bacillus atrophaeus or Bacillus subtilis (the organisms identified in this standard), you must prove that the organism you choose has demonstrated an equivalence and is suitably resistant.
This section goes into the exposure conditions required for compliance (at 54°C and/or 30°C), what the acceptable population range (≥ 1.0 x 106), and what the acceptable D-value range is (not less than 2.5 minutes at 54°C).
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