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ISO 11138-5

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ISO 11138-5 2nd Edition, March 1, 2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for lowtemperature steam and formaldehyde sterilization processes

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Description / Abstract: This document 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.