AAMI TIR30:2011/(R)2016 (PDF)
This report is intended as a resource for manufacturers of medical devices who must validate the
instructions for reprocessing that they include with their devices. In addition to describing
available processes, materials, test methods, and acceptance criteria for cleaning medical
devices that are labeled by the manufacturer for reuse and reprocessing, the report also
discusses some of the underlying problems and challenges associated with validating a cleaning
method. Extensive references and a sample cleaning validation outline and also are included.
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