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The photochemically etched titanium parts produced by Precision Micro meet the highest standards of cleanliness and could save medical device manufacturers time and money.
A Monocyte Activation Test (MAT) performed on human blood under FDA conditions achieved excellent results with 0.024 EEU/device and 75.4%. For the components to pass the test, they must not exceed 20 EEU/device. In addition, the maximum recovery must be between 50% and 200% according to FDA regulations. A cytotoxic test was also carried out to check the toxicity of the medical devices and materials. It showed that the parts did not have any cytotoxic potential.
The tests confirm that the human body tolerates the etched CMF implants well and increase confidence that the performance of the parts meets the highest standards. In practice, this means that the parts do not require further cleaning after production.
Markus Rettig, Sales Manager at Precision Micro said: "In the medical industry, all components must meet the highest standards to ensure best practices and ultimate safety. With these test results, we have proven how hard we work to help our customers meet these standards by ensuring optimal cleanliness. This may allow medical device manufacturers to save time and money in the future without compromising on quality and safety.
"Many companies in the industry produce such components by laser cutting. However, laser cutters must be cleaned very carefully because of the manufacturing process and the environment in which they are produced. This increases the overall production costs per piece if the required safety level is to be maintained".
"Our photochemical etching process is far superior to alternative manufacturing methods such as laser cutting because complex components can be produced quickly and with consistent quality and do not have to be reworked afterwards using alternative processes. As an ISO 13485 certified manufacturer, we have long met the highest standards, but these test results further confirm the many benefits of our process.
CMF implants generally undergo a four-step cleaning process to ensure their usability. This accounts for about half of the component costs. The fact that higher levels of cleanliness are ensured from the very first stages of production gives Precision Micro's customers greater confidence in the quality of critical components. In addition, they save costs for reworking and cleaning components.
Precision Micro produces hundreds of thousands of complex, burr-free and stress-free components for the medical industry every year.
