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Norm

ÖNORM EN ISO 11138-3

Issue date: 2006 11 01

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in as...
Withdrawn: 2010 01 01
Publisher:
Austrian Standards International
Format:
Digital | 13 Pages
Language:
German | English
This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by ISO 17665. NOTE 2 National or regional regulations may provide requirements for work place safety.
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