AAMI - ST67
Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ‘sterile’
|Publication Date:||1 January 2011|
This standard specifies requirements and provides guidance for selecting an appropriate SAL for a terminally sterilized health care product that is labeled "sterile." The requirements and guidance provided in this standard also apply to the selection of an appropriate SAL for a terminally sterilized health care product that is labeled "Sterile Fluid Path."
This standard does not address health care products that are not labeled "sterile." For example, nonsterile health care products that possess antimicrobial properties or contain preservatives for the control of microbial levels are not addressed.
This standard does not address the sterility of aseptically processed products.