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This document specifies requirements for test organisms, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.
NOTE Requirements for validation and control of VH2O2 sterilization processes are provided in ISO 22441.
This document does not cover biological indicators used for hydrogen peroxide (H2O2) biodecontamination systems such as those used for rooms, enclosures or environmental spaces.
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