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prEN ISO 11138-8

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO/DIS 11138-8:2020)

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ISO/DIS 11138-8; prEN ISO 11138-8
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1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7 day reference incubation time specified in 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. 1.2 This document is applicable to manufacturers of biological indicators and to end users of biological indicators who intend to, if required by their quality system, establish, validate or confirm an RIT. 1.3 This document is not applicable to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes. NOTE 1 The method described in this document to establish an RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish an RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes. NOTE 2 For EO as a sterilizing agent, the stated RIT will be applicable for any EO cycle type, i.e. 100% EO, EO blends, etc.
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