BS EN ISO 11138-1:2006 specifies general requirements for production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. Subsequent parts of ISO 11138 provide additional specific requirements for biological indicators for defined sterilization processes.
This part of BS EN ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of BS EN ISO 11138. Requirements for biological indicators for particular specified processes are provided in the other Parts. If no specific subsequent part is provided, this part applies.
It 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 part of ISO 11138, however, could contain elements relevant to such microbiological test systems.
