A new ISO Standard includes guidance for the selection, use, and interpretation of results from the application of biological indicators when used in the development, validation, and routine monitoring of sterilisation processes. ISO 14161:2009 Sterilization of health care products – Biological indicators – Guidance for the selection, use and interpretation of results applies to biological indicators for which Standards exist (for example, in the ISO 11138 series).
The information provided in ISO 14161:2009 can have useful application for processes and biological indicators not currently addressed by existing Standards, for example, new and developing sterilisation processes.
In ISO 14161:2009 users will find guidance on selection of the correct biological indicator for their particular sterilisation process and critical parameters as well as guidance on its appropriate use.
Summarised with permission from the British Standards Institute 'Health and medical devices newsletter', January 2010.
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