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Amorphous metal biocompatibility summary

 

A material’s success in the medical industry partly depends on its biocompatibility, and ability to be safely used in (or near) the human body. Most, if not all, medical devices must pass biocompatibility (ISO 10993) tests at some level.

For each category of contact (surface device, external communicating device, and implant device) there are three possible contact duration guidelines (less than 24 hours, 24 hours to 30 days, and greater than 30 days). In addition, there are several biological effects (cytotoxicity, sensitization, and more) that could occur.

Currently, stainless steels and titanium alloys are the most common materials used in medical devices. With thousands of potential applications for amorphous alloys in this market, LM105 having passed critical biocompatibility tests is a significant achievement. Materials that have passed ISO 10993 tests are relatively limited, which can put engineers in a bind when considering different manufacturing methods, and the respective costs, for their application.

Liquidmetal amorphous alloys offer a unique molding process and material properties to medical device manufacturers. A combination of strength (1524 MPa), hardness (53 HRC), elasticity (1.8%), precision (±0.0008”), and net-shape molding in a single step puts LM105 in a category of its own.

LM105 has passed cytotoxicity, sensitization, hemocompatibility, genotoxicity, and other external and surface tests in years passed. Recently, LM105 passed ISO 10993 long-term implantation studies. This is a significant step for the material, and drastically broadens the range of potential applications for Liquidmetal to components that remain in the body permanently.

This white paper summarizes the tests, as well as current corrosion resistance information. The PDF can be downloaded via the form below, and any questions for our team of amorphous metal experts are encouraged here.