1.1 General
1.1.1 This part of ISO 11138 provides 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.
1.1.2 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.
1.2 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.
Diese ÖNORM enthält allgemeine Anforderungen an die Herstellung und Kennzeichnung, Prüfverfahren und Leistungsmerkmale bei biologischen Indikatorsystemen, einschließlich beimpfter Keimträger und Suspensionen, und deren Bestandteilen, die bei der Validierung und Routineüberwachung von Sterilisationsverfahren verwendet werden.