EN ISO 11135-1 pdf download Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) This part of ISO 11135 does not cover analytical methods for determining levels of residual ethylene oxideand/or its reaction products. NOTE 7For further information see ISO 10993-7 NOTE...