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ANSI/AAMI ST67:2003

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."

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Association for the Advancement of Medical Instrumentation [aami]
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