scope:

General

This part of ISO 11138 provides general requirements for production, labeling, 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 part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

NOTE National or regional regulations may apply.

Exclusions

This part of ISO 11138 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.