The AAMI technical information report, TIR30:2011/(R)2016, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, and a proposed, and the 2015 Food and Drug Administration (FDA) guidance document, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, guide medical device manufacturers (MDMs) on cleaning validations for reusable medical devices. In a 2017 article, Turtil and Jain reviewed updates to TIR30. The AAMI Sterilization Standards Committee working group, ST/WG 93 (Cleaning of Reusable Medical Devices Working Group) decided that a standard rather than a revised TIR would better serve the MDM community and drive harmonization regarding cleaning validation requirements. In 2019, ST/WG 93 reviewed the first committee draft of ST98.
TIR30 and ST98 have two main differences. The first difference is related to the scope of the documents: TIR30 covers reusable medical devices, while AAMI ST98 has a broader range and applies to devices that require processing before clinical use per the Spaulding scale, including single-use devices that require processing by the healthcare facility prior to use. The other key difference is that instead of only providing an overview of cleaning test methods, ST98 lists the requirements for cleaning validations. . .
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