Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"

Published by	Publication Date	Number of Pages
AAMI	07/29/2019	41

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Category: AAMI

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AAMI ST67 – 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^-6.