ISO-11138-4 › Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
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ISO 11138-4:2017 specifies 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 20857.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
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Document Number
ISO 11138-4:2017
Revision Level
2ND EDITION
Status
Current
Publication Date
March 1, 2017
Committee Number
ISO/TC 198