BS EN ISO 11138-1:2017 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 ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.

NOTE National or regional regulations can apply.

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.


Cross References:
ISO 11135
ISO 11737-1:2006
ISO 14937
ISO 17665-1
ISO 18472
ISO 8601
ISO/TS 11139:2006
ISO 11140-1
ISO 13485
ISO 14161:2009
ISO 15223-1
ISO 80000
IEC 60027


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