Standard: AAMI 11138-5
STERILIZATION OF HEALTH CARE PRODUCTS-BIOLOGICAL INDICATORS-PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE 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 sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.
NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 11138-5|
|Change Type:||COMPLETE REVISION|
|Most Recent Revision:||YES|