There’s a new ASTM F2989 2013 Edition, “Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications.” The document covers the chemical, mechanical and metallurgical requirements for three grades of metal injection molded unalloyed titanium components to be used in the manufacture of surgical implants.
The metal injection molded (MIM) titanium in ASTM F2989-13 makes use of 2 types as well as the 3 grades. The chemical composition matches up to ASTM F67 except for the maximum oxygen level of Grade MIM 3.
The standard provides for both the use of SI (preferred) and inch-pound units without the use of the ASTM F2989/F2989M designator. This is because ASTM is in the process of implementing a migration path that should culminate with total reliance on SI units by 2018.
Another thing to note in ASTM F2989 is the Appendix X2 on biocompatibility. It is informational and provides the user with a basis for evaluating the level of biological response to be expected when using this material. Appendix X1 – Rationale – includes the purpose; chemistry, process history and mechanical properties; fatigue; binders; and units of measurement.
ASTM F2989 was developed not only for manufacturers and medical device companies, but also to serve as a basis for certification by testing laboratories and as a guideline for regulatory bodies. It supports the design of new shapes and allows MIM components to be directly compared to parts made by more conventional methods.
The 2013 Edition is an update of the ASTM F2989 2012 Edition. For the details on the changes, you’ll want to purchase the redline edition. This comes with a clean copy of the 2013 revision plus a copy of the 2012 document with the changes marked clearly for your review.
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