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About This Item
Full Description
This International Standard 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. This International Standard applies to biological indicators for which International Standards exist.
This International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.
This International Standard is not intended to apply to combination processes, using for example washer disinfectors or flushing and steaming of pipelines.
This International Standard is not intended to apply to liquid sterilization processes.
Document History
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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- Most Recent
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ISO 14161:2009
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results- Historical Version
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ISO 14161:2000
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Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results- Historical Version