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Description of BS EN ISO 11138-1:2017 2017This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. This document specifies basic and common requirements that are applicable to all parts of ISOÂ 11138 . Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISOÂ 11138 . If no specific subsequent part is provided, this document applies.
This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
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About BSIBSI 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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