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 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.

If you have additional questions or would like information on our Standards Online cloud access service for your company, please get in touch.  We can be reached by phone (650-591-7600) and email (  We’ve been working with standards since 1982.  You’ll find our staff to be knowledgeable.  And we have a complete suite of support services to help you keep your compliance documentation in good shape.  Make us your Standards Experts!

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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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