Nitinol Q&A
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Are there good data on the biocompatibility of nitinol? Has anybody done Class VI or ISO 10993 testing on it?Answered April 29th, 2010 by Expert:There are lots of good data on nitinol biocompatibility. Every medical implant commercialized in the United States is subjected to some, if not all, of the tests required by ISO 10993—the biological evaluation of medical implants. However, these tests are unique to specific designs and surface finishes and are generally proprietary.
There are also quite a bit of published data in the literature. For example, a PubMed search on nitinol biocompatibility yields 81 publications, and there are also a few biocompatibility-related publications available on the NDC Web site.

