AAMI TIR15 2016 Edition has just been released. This Technical Information Report is titled Physical aspects of ethylene oxide sterilization. It has been written to provide additional guidance for the ANSI/AAMI/ISO 11135. Since the ANSI/AAMI/ISO 11135 was revised in 2014, there was a need to update the TIR as well. The new 2016 Edition replaces the previous 2009 Edition, which is now obsolete.
Topics covered by the AAMI TIR15 are sterilization equipment, considerations for preconditioning, calculations for relative humidity, calculations of ethylene oxide (EO) concentration, and flammability. Also covered are some of the physical aspects of ethylene oxide sterilization.
The AAMI TIR15 begins with the usual scope and definitions sections. The next topic covered is EO sterilization processing equipment. The report then moves on to how to determine the minimum product temperature needed prior to preconditioning. Methods for calculating the moisture content, the EO concentration, and the use of the flammability curve follow. Section 8 is a guide for using statistical comparison for determining the process equivalence. A 28-item bibliography completes this 37-page report.
The supporting documents for medical device sterilization, like the TIR15, help the healthcare community comply with safety standards. Since the publication is covered by copyright, you’ll want to make sure you purchase your copy from an authorized distributor like Document Center Inc. You can search for and order standards at our webstore, www.document-center.com. Here is a direct link to the order page for AAMI TIR15 2016 Edition for your convenience.
Regulatory compliance requirements for documentation can challenge many a medical device professional. When you use Document Center Inc. as your supplier, you’ll find that we offer a level of support unmatched by other alternatives. Our staff is knowledgeable, and we have a wide array of services all geared to providing you with the information you need for compliance. Contact us by phone (650-591-7600) or email (firstname.lastname@example.org) to learn more. Find out why so many medical device companies make us their Standards Experts!