AAMI TIR30:2011/(R)2016 [HISTORICAL]

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. This document has been superseded by ANSI/AAMI ST98:2022; Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices. This document is no longer being maintained by AAMI and should not be used for new designs.  Every AAMI standard is subjected to review at least every five (5) years. When a standard is more than five years old, has not undergone revision or review, and/or no longer carries the ANSI designation, it is reasonable to conclude that the contents, while still of some historic value, do not reflect the present state of the art. All copyrights remain in full effect. No annex