ANSI/AAMI ST108 Water for processing medical devices

Chrisx

Quite Involved in Discussions
We are a contract manufacture of orthopedic devices and utilize DI water for removing process agents following a validated cleaning process per ISO 19227. There is very little information on ANSI/AAMI ST108 on the AAMI or ANSI websites. There is no preview of the initial scope statement or introduction. I suspect this standard is intended for reprocessing, which we do not perform. I don't want to waste money buying standards that don't pertain to our processes. Currently, our water meets requirements for WFI and has microbial limits, so it's very clean. Anyone have any experience with this standard and whether it only pertains to reprocessing?
 

planB

Super Moderator
Per its title (ANSI/AAMI ST108:2023, Water for the processing of medical devices) and this introduction by publisher AAMI, this standard is only applicable to healthcare facilities that (re-)process medical devices, and thus is not applicable to manufacturers.
 
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