AAMI TIR35 – Medical Device sterilization

AAMI-TIR35, “Sterilization of health care products – Radiation sterilization – Alternative sampling plans for verification dose experiments and sterilization dose audits,” has just been updated.  This is a technical information report.  It is different from an AAMI standard.  It is released due to the immediate need within the medical device industry.

The AAMI TIR35 should be used in conjunction with the ANSI/AAMI/ISO 11137 series.  It describes how the number of items used as a sample for establishing and maintaining the sterilization dose can be reduced from the 100 items required in Methods 1 and 2 of ANSI/AAMI/ISO 11137-2.  The method in TIR35 is statistically equivalent to that of the 11137-2.

Another  area where the AAMI TIR35 provides guidance is for accepting new or redesigned products into an established product family using a technical evaluation.  You’ll use the TIR35 to determine what method you’ll use in order to do this.

FYI:  The TIR35 was adopted from the ANSI/AAMI/ISO 15843, 2000 Edition.  That document is now obsolete, having been replaced by the TIR35.

Since the 2006 Edition of TIR35 is now withdrawn, you’ll need the new 2016 Edition if you use this publication.  Get your copy from Document Center Inc., an authorized distributor of the AAMI standards.  You can search for and order these documents at our webstore, www.document-center.com.  Here’s a direct link to the order page for AAMI TIR35 for your convenience.

If you need more help, just get in touch with our staff.  You can reach us by phone (650-591-7600) or by email (info@document-center.com).  We’ve been selling standards since 1982.  Make us your Standards Experts!

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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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