AAMI TIR29, “Guide for process control in radiation sterilization,” has just been released and is available in either paper or pdf format from Document Center Inc. This technical information report provides additional guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state.
This document is intended to complement qualification and routine control activities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization.
This document is the second edition of AAMI TIR29. It is now more closely aligned with the general format/section headings of ISO 11137-1 and eliminates redundancies of ISO 11137-3. This second edition is expanded to encompass process characterization and process control, address X-ray sterilization, and provide more guidance regarding additional dose mapping studies, mapping, and processing families. It also incorporates information regarding process equivalency in cobalt-60 radiation sterilization facilities.
The new 28-page 2012 Edition replaces AAMI TIR29 2002, which is now obsolete. In spite of the fact that it is aligned with the ISO 11137 series, there is no equivalent International Standard for this AAMI release. The document is cited by the FDA as relevant guidance.
All current and many obsolete AAMI standards are available from Document Center Inc. under license agreement. AAMI documents can be purchased at our webstore, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We provide documentation sales and support services to many medical device manufacturers and can help you with your compliance requirements.
could you send one copy to me?
Hi Michael:
Thanks so much for asking.
All AAMI standards are covered by U.S. copyright law. You’ll need to purchase any AAMI standards you’re interested in. You can do this by going to the Document Center Inc. website at http://www.document-center.com. We’re a licensed distributor of the AAMI Standards.
If you’d rather check in with us directly, just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We can make sure you get a copy of the document asap!
Thanks,
Claudia