scope:

Inclusions

This standard specifies requirements and provides guidance for selecting an appropriate SAL for a terminally sterilized medical device or a maximum contamination rate for an aseptically processed medical device 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 medical device that is labeled "Sterile Fluid Path."

Exclusions

This standard does not address medical devices that are not labeled "STERILE." For example, nonsterile medical devices that possess antimicrobial properties or contain preservatives for the control of microbial levels are not addressed. This standard also does not address products regulated as drugs or biologics by the FDA.