AAMI ST58:2013

Chemical sterilization and high-level disinfection in health care facilities

Published by: Association for the Advancement of Medical Instrumentation / 08/21/2013 / 168 pages
This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and other health care facilities. These guidelines are intended to assist health care personnel in the safe and effective use of gaseous chemical sterilizing systems, LCSs/HLDs, and associated equipment.

Included within the scope of this recommended practice are functional and physical design criteria for chemical sterilization and high-level disinfection processing areas; staff qualifications, education, and other personnel considerations; criteria for selecting LCSs/HLDs and gaseous chemical sterilizers; safety and efficacy considerations in the use of LCSs/HLDs and gaseous chemical sterilizers; preparation of devices for processing by chemical sterilization or high-level disinfection; quality control methods; and qulaity process improvement. Definitions of terms and informative annexes are also provided.

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