ANSI/AAMI/ISO 11138-2:2006 (R2010)

Sterilization of health care products -Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

Provides specific requirements for test organisms and biological indicators intended for use in assessing the performance of sterilizers employing pure ethylene oxide gas or admixtures of the gas with diluent gases at sterilizing temperatures within the range of 20 degree Celsius to 65 degree Celsius.

Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought
Sterilization of health care products - Biological indicators - Part 1: General requirements
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Clinical investigation of medical devices for human subjects - Good clinical practice (contains erratum)
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