AAMI TIR14 – Contract Sterilization

AAMI TIR14 for medical device contract sterilization has been updated.  The new 2016 Edition replaces the 2009 Edition, which is now obsolete.  The title for this new update is “Contract sterilization using ethylene oxide.”  It is one of AAMI’s technical information reports.

The AAMI TIR14 was developed to help medical manufacturers that use contract sterilization facilities or for those facilities themselves.  It is a companion to the ANSI/AAMI/ISO 11135.  As such it applies to ethylene oxide operations for devices marketed in the U.S.  Please note:  it does not address this type of sterilization in health care facilities like hospitals.

What’s covered in this new edition?  It has the usual scope and definition clauses to start.  Then information on how to choose a sterilization facility is provided.  You’ll get guidance on the written agreement that’s used between the product manufacturer and the contract facility.

Then the nuts and bolts of processing are covered.  This includes the validation program, handling of various samples, processing documentation and controls.  A 30-item bibliography completes the publication.

The new edition of the TIR14 was written in response to the release of the 2014 Edition of the ISO 11135 and it’s ANSI/AAMI adoption.  FYI:  The ANSI/AAMI/ISO 11135 2014 Edition is an FDA recognized consensus standard.  So, the additional guidance of the AAMI TIR14 can be very helpful in implementing this document.

If you are interested in purchasing a copy of the new Technical Information Report, choose Document Center Inc. as your supplier.  You can order at our webstore, www.document-center.com.  Your purchase will come with our best-in-class notification service at no additional charge.  Here is a link to the order page for AAMI TIR14 for your convenience.  Should you prefer, you can reach us by phone (650-591-7600) or email (info@document-center.com).

Of course, if you’re in the medical device industry, you’ve got a number of regulatory and compliance concerns.  For your standards requirements, Document Center has a wide range of products and services.  Many medical device manufacturers rely on Document Center to support their compliance efforts.  Make us your Standards Experts too!

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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