This standard 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 for use in hospitals and other healthcare facilities. Included within the scope of this standard are functional and physical design criteria; staff qualifications and education; criteria for selecting LCSs/HLDs and gaseous chemical sterilizers; safety and efficacy considerations in the use; quality control methods; and quality process improvement.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.