EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
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 andsterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxidegas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 ℃ to 65 ℃.
EN ISO 11138-2:2009 Referenced Document
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment*, 2018-07-31 Update
EN ISO 11138-2:2009 history
2017EN ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
2009EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
2006EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes has been changed from BS EN ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Biological indicators for ethylene oxide sterilization processes.