Medical device manufacturers need to do a battery of testing prior to the release of any products as part of regulatory and quality requirements. Biological evaluation, the interaction of the device with biological tissues, is a major concern. So those in the medical device industry will want to know that there’s a new 3rd Edition available for ISO 10993-3. Titled “Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity,” this is part of the 19-document series from ISO. It is a technical revision of the 2nd edition (which is now obsolete) and is 42 pages in length compared to the previous 23 page revision.
What are the changes in the ISO 10993-3 3rd Edition? As you can see from the additional pages, there’s a lot of new material. Let’s review the areas where the standard has been updated:
- The test strategy of the standard has been modified by the addition of an in vivo test and follow-up evaluation.
- There’s a new Annex A which provides guidance on selecting the appropriate sample preparation procedure in genotoxicity testing. This includes further in vitro and in vivo tests.
- There’s also a new Annex B that’s a flowchart for follow-up evaluation.
- Annex E has been changed to “Considerations for carcinogenicity studies performed as implantation studies.” This is a requirement now, not just informative.
- And there’s a new Annex F on in vitro tests for embryo toxicity as well.
Other news for those of you who use this standard — A new ISO 10993-33 is in the works. When it is published, it is expected that the title will be “Biological evaluation of medical devices – Part 33: Supplement to ISO 10993-3: – Guidance on tests to evaluate genotoxicity.” The document should be released as a Technical Report.
You’ll want to purchase a copy of the new edition, so head to the Document Center Inc. website at www.document-center.com and order your copy now. You’ll be able to get the standard in both paper format and for pdf download. If you’d like to have it as part of our Standards Online multi-use subscription service, contact our staff by phone (650-591-7600), email (info@document-center.com) or fax (650-591-7617). We’re here to assist you with your compliance documentation requirements. Make us your Standards Experts!
