July 2, 2021

Should simulated use testing always be a part of your reprocessing validations?

Simulated use is defined as “use that mimics the intended use of the medical device”[1]. In guidance documents such as the AAMI TIR12:2020[2] or AAMI TIR30:2011[3] simulated use testing often refers to test soil selection, specifying that “the test soil...