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Full Description

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.

Document History

  1. AAMI ST58:2013


    Chemical sterilization and high-level disinfection in health care facilities

    • Most Recent
  2. AAMI ST58:2005/(R)2010

    Chemical sterilization and high-level disinfection in health care facilities

    • Historical Version
  3. AAMI TIR 7-99

    Chemical Sterilants and Sterilization Methods - A Guide to Selection and Use

    • Historical Version
  4. AAMI ST58-96

    Safe Use and Handling of Glutaraldehyde-Based Products in Health Care Facilities

    • Historical Version