Standardization News

A proposed standard from ASTM's medical and surgical materials and devices committee (F04) will be used to determine the fatigue strength of metallic components used in the development and manufacture of cardiovascular medical devices. Such devices include stents, heart valves, inferior vena cava (IVC) filters, endovascular prostheses, and other cardiovascular devices with metallic components.

The proposed standard (WK88773) will aid in the selection and creation of test specimens (components, coupons, or surrogates) for fatigue strength determination, as well as provide guidance on conducting tests and analyzing results. In addition, the proposed standard will also address strategy for selecting the number of samples and test conditions, such as mean and alternating load levels.

“As part of developing durable cardiovascular medical devices that can withstand the various cyclic mechanical loads in the body, a combination of experiments and computational simulation is typically used, which results in the calculation of fatigue safety factors,” says ASTM member Jason Weaver. “The fatigue strength associated with the device material is necessary for the fatigue safety factor determination.”

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