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ISO 11138-7:2019

ISO 11138-7:2019

$50.70

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

Published By Publication Date Number of Pages
ISO 2019-03 72
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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.

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ISO 11138-7:2019
$50.70