AAMI TIR12, 2010 Edition, titled “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers,” is one of the best selling new releases here at Document Center Inc.
This technical information report (TIR) covers design considerations that medical device manufacturers need to consider when developing products that need to be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities. This means that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annexes.
Please note: An AAMI TIR like this one is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board.
The document, and all AAMI publications, are available from Document Center Inc. at our website, www.document-center.com. Or contact us via phone (650-591-7600), fax (650-591-7617), or email (firstname.lastname@example.org). We’ll be happy to help you with all your standards requirements.--