Tag: ISO 11137-2:2012

New ISO 11137-2 3rd Edition – Medical Device Sterilization

ISO 11137-2, “Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose,” has just been revised.  You can buy the paper format or download the pdf from Document Center Inc. now.  The new ISO 11137-2 3rd Edition cancels and replaces the previous ISO 11137-2:2012.  It is considered a minor revision.

ISO 11137-2:2013 describes methods that can be used to establish the sterilization dose in accordance with 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.” The methods used in these approaches are:

  • dose setting to obtain a product-specific dose and
  • dose substantiation to verify a pre-selected dose of 25 kGy or 15 kGy.

The changes that occur in the ISO 11137-2 3rd Edition cover modifications to sections 9.1 and 10.3.4.1.  There is also correction of the language used to describe the requirements for the interpretation of results in the following sections: 7.2.6.2, 7.3.7.2, 9.2.6.3, 9.3.7.3, 9.4.6.3, and 9.5.7.3.

Other standards of interest beyond the ISO 11137-1 and ISO 11137-2 include:

  • ISO/TS 11139, Sterilization of Health Care Products – Vocabulary
  • ISO 11737-1, Sterilization of Medical Devices – Microbiological Methods – Part 1: Determination of a Population of Microorganisms on Products
  • ISO 11737-2, Sterilization of Medical Devices – Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process

Our medical device clients rely on this information to insure that their products are sterile when delivered to their customers or to end users.  If you would like to participate in the development of these types of documents, AAMI is the U.S. TAG (Technical Advisory Group) leader for the involvement of U.S. organizations in the process.  If you live outside the U.S., see your National Standards Body for information.

These standards have been widely adopted so there are numerous republications from various jurisdictions.  If you are using a national or regional adoption of the ISO 11137-2, your copy should be updated shortly.

The above standards are available in their original format and in the many adopted editions from Document Center’s web store, www.document-center.com.  Or feel free to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are a licensed distributor of standards from many sources and remain Your Standards Experts.

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.