ISO/TR 10993-33, “Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3,” has just been released. It’s available from Document Center in paper format, for pdf download, and as part of our multi-user Standards Online service. It will give you an overview of the differences in various regulatory bodies regarding genotoxicity testing. And it will help you choose what tests to use and provides guidance on the performance of those tests.
What are genotoxicity tests? They are used to detect compounds that induce genetic damage, either directly or indirectly. This is necessary because such compounds can be carcinogenic or may create germ line mutations (which can cause human disease).
The ISO/TR 10993-33 has the usual scope clause and then dives directly into the issue of what tests are commonly recognized for use by most regulatory agencies. This general information is linked to the various clauses in the technical report, so for bacterial reverse mutation test the user is directed to clause 6 and OECD 471. Clauses 4 and 5 cover an overview of both in vitro and in vivo tests.
Then the report clauses 6 to 11 cover six different tests. Each is given a general overview, preparations, test conditions, procedure and data and reporting sections. The six tests are:
- Bacterial reverse mutation assay
- In vitro mammalian chromosome aberration test
- In vitro mammalian micronucleus test
- In vitro mammalian cell gene mutation test using mouse lymphoma (L5278Y) cells
- In vivo mammalian erythrocyte micronucleus test
- Chromosome aberration test (in vivo)
A 33-item bibliography completes the publication.
As you can see, the document is highly technical, but offers the user detailed information that is not found in the shorter ISO 10993-3. Indeed, the bulk of the ISO/TR 10993-33 supplement is devoted to the tests themselves which will surely add clarification and detail to anyone currently using the Part 3.
Now you’ll want to get a copy. You can order online at the Document Center webstore, www.document-center.com. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been an authorized dealer of the ISO standards since the early 1990’s and selling standards from our Silicon Valley headquarters since 1982. Make us your Standards Experts!
