ISO 10993-11, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity, has just been updated. These types of tests help to confirm that a medical device is safe for the intended use. The new 3rd Edition is available now from Document Center Inc. This update cancels and replaces the previous 2006 2nd Edition. It is a technical revision.
For those of you in the medical device industry, finding and mitigating potential adverse effects is a top priority. Systemic toxicity is one of those effects you’ll need to address. These include such problems as leachates from your device or materials. The absorption and distribution of toxic materials from a medical device can cause concern. So ISO 10993-11 addresses various toxicity tests you’ll use to conduct a systemic toxicity study.
ISO 10993-11 is arranged in the usual fashion. There are sections on scope, referenced documents and terms at the start. Then Section 4 review the various general considerations you’ll need to address at the start of your testing.
Section 5 covers acute systemic toxicity, while 6 discusses repeated exposure issues. The publication then has 8 Annexes on relevant material, all informative. A 21-item bibliography completes the document.
For those of you already using this standard (and many of you are!), here is information on the changes in the 3rd Edition. As the committee notes in the forward to the publication, there is a reduction in the group size for chronic toxicity testing (Table 1), Annex F is now Annex G and a new Annex F has been added, Annex H has also been added, and the Bibliography has been updated.
The ISO 10993-11 2006 Edition was adopted by the EU. Adoption of this new edition is pending. Upon publication, acceptance as a new harmonized edition is expected.
Now you’ll need to get a copy of the new Edition. Choose Document Center Inc., an authorized distributor of the ISO Standards. Order at our webstore, www.document-center.com. Here is a direct link to the order page for the ISO 10993-11 for your convenience.
All ISO Standards are available as part of our Standards Online cloud-based access service. To learn more, please get in touch with our staff by phone (650-591-7600) or email (info@document-center.com). We have been working with standards since 1982 and offer you a complete support service for compliance documentation. Make Document Center your Standards Experts!
