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  • BSI
    BS EN ISO 11138-7:2019 Sterilization of health care products. Biological indicators - Guidance for the selection, use and interpretation of results
    Edition: 2019
    $569.57
    / user per year

Description of BS EN ISO 11138-7:2019 2019

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.



Standard NumberBS EN ISO 11138-7:2019
TitleSterilization of health care products. Biological indicators - Guidance for the selection, use and interpretation of results
StatusConfirmed
Publication Date2019-05-01
ReplacesBS EN ISO 14161:2009
Identical National Standard OfFprEN ISO 11138-7, ISO 11138-7, EN ISO 11138-7:2019
DescriptorsStatistical methods of analysis, Instructions for use, Medical equipment, Sterile equipment, Bioassay, Sterilization (hygiene), Biological analysis and testing, Medical instruments, Sterilizers, Selection
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 580 99278 0
PublisherBSI
Pages74

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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