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ISO 11138-4:2017

Current Date published:

Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes

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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  • AS/NZS ISO 11137.1:2006

    Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices

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  • BS EN 556-1:2024

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  • BS EN 556-1:2024 - TC

    Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices

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