Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
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BS EN ISO 14161:2009 Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results BS EN ISO 14161 is the standard that 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. BS EN ISO 14161 applies to biological indicators for which standards exist. See, for example, the ISO 11138 series . The general information provided in BS EN ISO 14161 can have useful application for processes and biological indicators not currently addressed by existing standards, e.g., new and developing sterilization processes. In BS EN ISO 14161 , users will find guidance on selection of the correct biological indicator for their particular sterilization process and critical parameters as well as guidance on its appropriate use. BS EN ISO 14161 is not intended to mandate the use of biological indicators in a process but, if they are used, it provides guidance for their proper selection and use in order to obviate misleading results. BS EN ISO 14161 describes procedures of a general nature and that which do not constitute a comprehensive development, validation or monitoring programme with regard to the sterilization of health care products. The user should select a biological indicator that is appropriate for the particular process to be used. There is a wide variety of sterilization processes in common use, and biological indicator manufacturers are not able to foresee all possible uses of their product. Manufacturers, therefore, lab...
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