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

Standard No.

ANSI/AAMI/ISO 11138-8:2023

Published By

American National Standards Institute （ANSI)

Latest

ANSI/AAMI/ISO 11138-8:2023

Scope

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.

ANSI/AAMI/ISO 11138-8:2023 history

• 1970 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