Tag: Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose

AAMI/ISO 11137-2 2013 Edition is here – Sterilization of Health Care Products

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.

Feel free to order 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 the kind of personal expert service that’s missing from the other standards resources out there.  And we offer a full range of services to help you maintain a current and complete standards collection in order to meet your compliance requirements.

There’s a new ISO 11137-2 2012 Edition, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose

The International Organization for Standardization (ISO) has just released the new 2nd Edition for ISO 11137-2, “Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.”   Widely adopted, the standard specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility.  It is available from Document Center Inc. now.

The standard provides methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6.  It also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

In addition, ISO 11137-2:2012 defines product families for sterilization dose establishment and sterilization dose audit.  It is one of a 3-part series on the sterilization of health care products using radiation that replaced the original edition, ISO 11137:1995.  The other two documents in the series are:

  • ISO 11137-1:2006, “Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”
  • ISO 11137-3:2006, “Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects”

There is a draft amendment in process for the ISO 11137-1 so we may see additional activity on that item as well.

Because the document is so widely adopted by other standards jurisdictions (the European Union, the U.S. and so on), we expect to see the usual trickle down effect, with new editions of the adoptions being issued soon.

All ISO standards are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re happy to assist you with all your Standards and Compliance requirements.