Scope: This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.

It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.

It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.

It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.

It is not applicable to liquid immersion sterilization processes.

Cross References:
ISO/IEC Guide 2
ISO 18472
ISO 11737 (all parts)
ISO 14937
ISO 20857
ISO 11135
ISO 9001
ISO 11138 (all parts)
ISO 13485
ANSI/AAMI ST79
EN 1422
EN 285
ISO/IEC 17025
ISO 17665-1
ISO 19011
ISO/IEC 17011
ISO 11139:2018


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