EVS-EN ISO 11138-1:2017

ISO 11119-1 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators to be used in the validation and routine monitoring of sterilization processes. It includes inoculated carriers and suspensions and their components. It specifies basic and common requirements that apply to all parts of ISO 11138. Requirements for biological indicators for specified processes are provided in the relevant parts of ISO 11138.

ISO 11119-1 does not apply to microbiological test systems for processes that rely on the physical removal of microorganisms. This means filtration processes or processes that combine physical or mechanical removal with microbiological inactivation, such as the use of washer disinfectors or flushing and steaming of pipelines. ISO 11119-1, however, can contain elements relevant to such microbiological test systems.

The text of ISO 11138-1:2017 has been approved in Europe as EN ISO 11138-1:2017 without any changes.