Most recent
ANSI/AAMI ST67:2019
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
This standard establishes requirements, guidance and a risk framework for identification of acceptable approach(es) for assurance of sterility and for selection of alternative SAL(s) or aseptic processing for health care product that cannot be terminally sterilized to achieve an SAL value of 10 to the -6
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]