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DIN EN ISO 11138-8:2021 Edition

DIN EN ISO 11138-8:2021 Edition

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Sterilization of health care products – Biological indicators – Part 8: Method for validation of a reduced incubation time for a biological indicator (Draft)

Published By Publication Date Number of Pages
DIN 2021-02 25
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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. 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. 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.

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DIN EN ISO 11138-8
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