Historical
ANSI/AAMI ST67:2003/(R)2008
Sterilization of health care products - Requirements for products labeled "STERILE"
Establishes requirements and provides guidance for the selection of an appropriate Sterility Assurance Level (SAL) for terminally sterilized medical devices labeled "sterile." Also establishes acceptance criteria for maximum contamination rates for aseptically-filled products labeled "sterile."
Content Provider
Association for the Advancement of Medical Instrumentation [aami]