SS-EN-ISO-14161 › Historical Revision Information
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2000)
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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. NOTE 1 See for example the ISO 11138 series. NOTE 2 The general information provided in this International Standard may have useful application for processes and biological indicators not currently addressed by existing International Standards, e.g. new and developing sterilization processes. 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.
To find similar documents by classification:
11.040.01 (Medical equipment in general)
11.120.01 (Pharmaceutics in general)
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Designation Name
SS-EN ISO 14161
Revision Level
EDITION 1
Status
Superseded
Publication Date
Feb. 9, 2001
Language(s)
English
Page Count
46
International Equivalent
EN ISO 14161:2000(IDT); ISO 14161:2000(IDT)