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.
NOTE1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO11135 and ISO14937 .
NOTE2 National or regional regulations can provide requirements for work place safety.