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AAMI ANSI/AAMI/ISO 11138-8:2023

Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator
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AAMI ANSI/AAMI/ISO 11138-8:2023

Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator

PUBLISH DATE 2023
AAMI ANSI/AAMI/ISO 11138-8:2023
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 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 11138-8
Publication Date Aug. 31, 2023
Language en - English
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