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ISO DIS 11138-1 2015 Edition, September 17, 2015 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
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Description / Abstract:
General
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.
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 can 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.