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AAMI TIR30:2011(R2016)

AAMI TIR30:2011(R2016)

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

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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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