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ISO 11138-4:2017

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ISO 11138-4:2017

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.

Author ISO/TC 198 Sterilization of health care products
Editor ISO
Document type Standard
Format Paper
Edition 2
ICS 11.080.01 : Sterilization and disinfection in general
Number of pages 8
Replace ISO 11138-4:2006
Weight(kg.) 0.1136
Year 2017
Country Switzerland