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.

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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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