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Norm
ÖNORM EN ISO 11138-1
Issue date: 2006 11 01
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
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,...
Withdrawn: 2017 07 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 45 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 11138-1
2017 07 15
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11...
Norm
ÖNORM EN ISO 11138-1
2006 11 01
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11...
Norm
↖
ÖNORM EN 866-1
1997 09 01
Biological systems for testing sterilizers and sterilization processes - Part 1: General requirement...
Norm
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