ISO 10993-6 Revised

ISO 10993-6, “Biological evaluation of medical devices – Part 6: Tests for local effects after implantation,” has just been revised.  The new 36-page 3rd Edition is dated 12/1/2016.  It is available now from Document Center Inc. in paper format, for pdf download and as part of our enterprise-access service Standards Online.  It is a technical revision of the previous 2007 Edition which is now obsolete.

ISO 10993-6 is an important tool for understanding how your implantable medical device affects the total health of the patient that is using it.  You’ll use it if your device contains materials that are solid (non-absorbable), degradable, or non-solid (gels, liquids, particulates and the like).  It provides you with implantation tests to evaluate tissue responses to your product.

What’s new in the ISO 10993-6 2016 Edition?  As noted above, this is a technical revision.  ISO/TC 194, the ISO committee responsible for this standard, notes that there are two main areas with updates.  The first is the addition of guidance on biological evaluation of absorbable medical devices.  The second is the addition of a new Annex D, a test method for implantation in brain tissue.

Has the ISO 10993-6 2016 Edition been adopted by other jurisdictions yet?  Not at this time.  The EN ISO 10993-6 2009 Edition is still current, for example.  However, the draft adoption of the new 2016 Edition is currently in the works.  We expect the release of the EN ISO 109936 2016 Edition to occur soon.  Just remember, once released this new EN standard will need to go through the formal administrative adoption process.   So it may be a while before it shows up on the Harmonized Lists for the medical device directives.  Expect the usual transition period for implementation in Europe.  The U.S. adoption (ANSI/AAMI/ISO 10993-6 2016) is also expected to occur soon.

Now to get your copy of the new standard.  Of course, you can search for and order standards from many different sources at the Document Center webstore, www.document-center.com.  For your convenience, here is a direct link to the order page for the ISO 10993-6 2016 update.  If you need a prior edition, you can review the document’s prior activity on the history page as well.  We have many of the ISO standards in house for immediate delivery.

You may have additional questions or want more information on getting company-wide access to standards.  Contact our staff by phone (650-591-7600) or email (info@document-center.com) for more information.  We have been working with standards since 1982.  Make us your Standards Experts!

The ISO 10993 Series on Biological evaluation of medical devices

The ISO-10993 Series on Biological Evaluation of Medical Devices is an essential part of every Medical Device company’s standards collection.  They are among Document Center’s all-time best selling Medical Device Standards.

The ISO-10993 Parts cover a broad range of principles and tests for the biological evaluation of medical devices within a risk management process.  Medical devices are categorized by the nature and duration of the contact of the device with the body.  The series helps the user identify and evaluate existing relevant data, identify gaps using risk analysis, identify where further information is necessary, and provides guidance on needed testing.  It is a must-have series for medical device manufacturers, researchers, laboratories, and regulators.

New releases in this  series (dated in 2010) are the Corrigendum 1 (Correction Sheet) for the ISO-10993-1, the ISO-10993-10:2010, the ISO-10993-13:2010, and the ISO-10993-16:2010.

Here’s the complete list of 10993 Standards.

  • ISO 10993-1 – Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2 – Biological evaluation of medical devices Part 2: Animal welfare requirements
  • ISO 10993-3 – Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4 and Amd 1 – Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
  • ISO 10993-5 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-6 – Biological evaluation of medical devices Part 6: Tests for local effects after implantation
  • ISO 10993-7 – Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
  • ISO 10993-8Withdrawn – Biological evaluation of medical devices Part 8: Selection and qualification of reference materials for biological tests
  • ISO 10993-9 – Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10 – Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
  • ISO 10993-11 – Biological evaluation of medical devices Part 11: Tests for systemic toxicity
  • ISO 10993-12 – Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
  • ISO 10993-13 – Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14 – Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15 – Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-16 – Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
  • ISO 10993-17 – Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-18 – Biological evaluation of medical devices Part 18: Chemical characterization of materials
  • ISO/TS 10993-19 – Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
  • ISO/TS 10993-20 – Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices

The complete set can be purchased as a package as well (ISO-10993-Package).  Contact Document Center Inc. at 650-591-7600 or on our website at www.document-center.com.