AAMI/ISO 11137-2, “Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose,” has just been released. You can purchase your copy in either paper format or for pdf download from Document Center Inc. The document is the adoption of the ISO 11137-2 from this year. Also known as ANSI/AAMI/ISO 11137-2, the standard is intended to be used with ANSI/AAMI/ISO 11137-1 to support clause 12.
I’ve blogged about the new 2013 Edition of ISO 11137-2 recently. The technical changes in the ANSI/AAMI/ISO 11137-2 are the same, since the document is a direct adoption and reprinting of the source document, with AAMI administrative information at the beginning of the publication.
This document provides the user with the methods for determining the minimum dose of radiation used for the sterility of health care products. This includes methods to substantiate 25kGy as the sterilization dose. It does this by defining product families for sterilization dose establishment and audit.
If you use the ISO standard, you’ll know that the majority of the changes throughout the 2013 version of ISO 11137-2 were to harmonize parallel sections for the various methods. This was done to provide improved clarity, readability and precision of the terminology used in the document. And additional minor changes were made to sections 9.1 and 10.3.4.1.
And for those of you who prefer to get the AAMI reprints of ISO standards, the AAMI adoption of ISO/TR 24971 2013 Edition has also been released. This standard, ANSI/AAMI/ISO TIR 24971, “Medical devices – Guidance on the application of ISO 14971,” covers the same material as the ISO/TR 24971. For more information on this new publication, see my recent blog on the ISO/TR 24971 1st Edition.
When you order from Document Center, you can rest assured that the documents are either original copies from the Standards Developing Organization or are provided under license agreement. The bulk of the cost of the document goes directly to the copyright holder.
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