Standards Development

Scope

1.1 This document specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.

1.2 This document specifies requirements for ethylene oxide sterilizers (EO sterilizers) for:

— the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;

— the equipment and controls of these sterilizers, needed for operation, control and monitoring of the sterilization processes;

— the test equipment and test procedures used to verify the sterilizer performance specified by this document.

1.3 This document does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.