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U.S. Department of Health and Human Services

About FDA

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FY 2000 Device Performance Analysis And Modeling

The development of test methodologies and performance requirements for devices and materials are vital for industry’s consensus standards. OST’s program has two areas of focus. The first is developing chemical test methods that determine the accuracy and precision of analytical instruments or the performance of devices that rely on mass transfer. The second is developing test methods for devices and materials involving performance requirements such as strength, durability, abrasion resistance, puncture resistance, etc. This program area allowed OST to participate in the technical reviews of numerous new products such as bioprosthetic heart valves and tissue adhesives.

Endovascular Stent Standards Development
Key words: stents, standards, test methods

OST laboratory personnel, in collaboration with ODE and industry and under the auspices of ASTM, are continuing to develop detailed test procedures for clinically relevant engineering attributes of endovascular stents. The ASTM Interventional Cardiology Task Group, co-chaired by OST and supported by data generated by the OST laboratory effort, has completed work on two standards. The data to support precision and bias statements for these methods are being developed. Significant effort was spent evaluating the details of stent dimensional characterization, including the diameter measurements used for the calculation of recoil. The stents on hand were characterized by a variety of methods (profile projection, pin gages, laser micrometer, calipers) with a view toward quantifying both the precision of the method and the variation in dimension across the stent. Preliminary data indicate that further development of the methodology is necessary if the precision goals for the standard test methods are to be met.