Tag: Sterilization of health care products — Radiation — Part 1: Requirements for development validation and routine control of a sterilization process for medical devices

New Amendment 1 for ISO 11137-1 2006 Edition – Sterilization of Health Care Products

Some documents are essential for the Medical Device manufacturer.  ISO 11137-1 2006 Edition, “Sterilization of Health Care Products – Radiation – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices,” is one such standard.  And the new 10-page Amendment 1 for this 1st Edition has just been released.

This Part 1 of ISO 11137 describes requirements to provide a radiation sterilization process for sterilizing medical devices.  Compliance with the requirements ensures that this activity is both reliable and reproducible.  This allows for confidence in that there is a low level of probability that a viable microorganism is present on product after sterilization.

The new amendment 1 provides you with 4 pages of pen-and-ink changes that you’ll need to make to your copy of ISO 11137-1.  Some changes are minor (replacing “ISO 11137-2:2006” with “ISO 11137-2” to reflect the fact that there is a new 2013 Edition of Part 2).

However, there other changes that are more substantial.  They include 2 replacement entries in the Terms and definition section (3.29 and 3.31).  Other sections with changes include 6.2.5, 12.1.1, 12.1.2.5, 12.1.3.1, 12.1.3.2, A8.4.1,  A8.4.2.1, A.8.4.2.2, A8.4.2.3, and A.12.1.2.5.

If you’re using this standard, you’ll want to purchase the new Amendment 1 for ISO 11137-1.  Go to our web store at www.document-center.com and order online.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been providing standards to the medical device community for many years now.  We have the expertise to assist you with your standards requirements and questions.  Make Document Center 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.