Standard: AAMI 11138-2
STERILIZATION OF HEALTH CARE PRODUCTS-BIOLOGICAL INDICATORS-PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
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This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 11138-2|
|Change Type:||COMPLETE REVISION|
|Most Recent Revision:||YES|