ISO 11138-5:2017

Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

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Referenced standards

EN 14180:2014ISO 11138-1:2017ISO 14161:2009ISO 14937:2009ISO 25424:2009
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ISO 11138-5:2017

Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.

NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

Edition2017
Standard Part No5
Published Date2017
Published ByInternational Standardization Organisation
Page Count7