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ISO 11138-7:2019

Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results

Publication date:   Mar 12, 2019

General information

90.93 Standard confirmed   Jul 5, 2024

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14161:2009

NOW

PUBLISHED
ISO 11138-7:2019
90.93 Standard confirmed
Jul 5, 2024