AAMI TIR28 has been updated. The new 22-page 2016 Edition is titled Product adoption and process equivalence for ethylene oxide sterilization. It is a Technical Information Report. It is intended to be used in conjunction with ANSI/AAMI/ISO 11135 from 2014. It provides information on correctly sterilizing medical equipment in healthcare environments.
The AAMI TIR28 provides guidance on how to bring new or modified products into an existing validated sterilization process. One part of this process involves establishing equivalence between the existing processes and the level of microbiological performance required for the new items. The Report also addresses maintenance of equivalence and requalification once that equivalence has been established.
Please note that AAMI TIR28 can be used for new products, changes to products that have already been validated, moving a validated process to a new facility or new equipment, and to evaluate the equivalency of a sterilization process.
The AAMI TIR28 was updated due to changes in the ISO standard that it applies to. If you need copies of the AAMI Report or any relevant ISO standards, consider using Document Center Inc. for your purchase. As an authorized distributor, Document Center Inc. offers you access to over 1 million publications at our webstore, www.document-center.com. Here is a direct link to the order page for AAMI TIR28 for your convenience.
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