ANSI/AAMI/ISO 11138-8:2023

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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Details

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. Annex 3

Zusätzliche Information

Autor Association for the Advancement of Medical Instrumentation (AAMI)
Veröffentlicht von AAMI
Document type Normen
Thema Sterilization - Industrial
Schlagwort ANSI/AAMI/ISO 11138-8:2023