<p>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.</p>
<p>It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.</p>
<p>It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.</p>
<p>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.</p>
<p>It is not applicable to liquid immersion sterilization processes.</p>
Registration number (WIID)
74113
Scope
<p>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.</p>
<p>It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.</p>
<p>It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.</p>
<p>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.</p>
<p>It is not applicable to liquid immersion sterilization processes.</p>
