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BSI BS EN ISO 11138-3: Sterilization of health care products - Biological indicators Part 3: Biological indicators for moist heat sterilization processes

Publication Date: Nov 30, 2009
SDO: BSI: British Standards Institution
 DOD Adopted   ANSI Approved Approved

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.

Sterilizers
Sterilization (hygiene)
Medical equipment
Medical equipment
Microorganisms
Bioassay
Medical equipment
Microorganisms
Medical equipment
Medical equipment
Medical equipment
Medical equipment
Organism-activity determination

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