DIN 58948-7:2017-03

This standard specifies requirements for the installation and operation of ethylene oxide sterilizers and their supply sources in accordance with DIN EN 1422 with one or more fixed operating cycles for use in health care facilities and industry This standard applies to the operation of ethylene oxide sterilizers (EO sterilizers), preferably for the sterilization of thermolabile medical devices. NOTE 1 For the requirements of fully automated EO sterilizers, see Technical Rules for Hazardous Substances (TRGS 513). NOTE 2 Although the scope of this standard is limited to medical devices, it establishes requirements and provides guidance that could also apply to other products, devices and fields of application. This standard is not applicable for the sterilization of liquids, pastes and powders.