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 sterilization processes employing moist heat as the sterilizing agent.
Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.
NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665.
NOTE 2 National or regional regulations may provide requirements for work place safety.
BS EN ISO 11138-3:2009 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
BS EN ISO 11138-3:2009 history
2017BS EN ISO 11138-3:2017 Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes
2009BS EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes
2006BS EN ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Biological indicators for moist heat sterilization processes