Tag: ISO 11137-3

ISO 11137-3 on Healthcare Product Sterilization Updated

ISo 11137-3 has been updated.  The new 2nd Edition is titled Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects of development, validation and routine control.  It is a technical update to the 1st Edition from 2006.  The older edition is now obsolete.

Radiation has been used for sterilization for some time.  It’s one tool used to sterilize medical devices, but of course dosage has to be measured carefully in this application.  ISO 11137-1 and ISO 11137-2 were developed to provide you with dosimetry requirements.  And the ISO/TS 13004 on the substantiation of the selected sterilization dose (method VDmaxSD) is also applicable.

ISO 11137-3 provides guidance on dosimetry (the use of dose measurements) during all stages of development, validation and routine control of your radiation sterilization process.  Unlike the other standards mentioned above, ISO 11137-3 is not normative (cannot be audited).  It is strictly a publication with information on how you can achieve compliance with the requirements of the other standards.

The 48 page publication includes basic information on dose measurement, establishing dosages, qualifications for installation, operation and performance, and routine monitoring and control.  Four additional informational annexes cover the following:

  • Mathematical modeling
  • Reference tables for dosimetry-related testing during IQ/OQ/PQ
  • Tolerances for ISO 11137-2 and ISO/TS 13004
  • Dose measurement uncertainty

A 33-item bibliography completes the publication.

If you use this standard, you’ll need a copy of the new Edition now.  Head to Document Center’s webstore at www.document-center.com to search for and order from our catalog of over 1 million standards.  Here is a direct link to the order page for ISO 11137-3 for your convenience.  And you may want to take a look at our Document Center List of Standards on Sterilization and Disinfection for other standards on this topic.

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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.