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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 14937.
NOTE 2 Requirements for work place safety may be provided by national or regional regulations.
ISO 11138-4:2006 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
ISO 11138-4:2006 history
2017ISO 11138-4:2017 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
2006ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes