AAMI ST98 is a new standard that provides specific requirements for medical device cleaning validations. Technical information report AAMI TIR30:2011 has historically been used to offer guidance on reusable medical devices, however ST98 will impact how device manufacturers and laboratories execute cleaning validations.

This article will include details regarding: validation of extraction methods, extraction efficiency requirements, TOC acceptance criteria, and justification for sample size.
New requirements for medical device cleaning validations – An overview of ST98
Author: Lori Graybill, Principal Scientist, Microbiology
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