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!
