ASTM F3067-14, published by the American Society for Testing and Materials (ASTM), provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and the chronic outward force of self-expanding vascular stents. This standard applies to balloon-expandable and self-expanding stents with tubular geometry. It covers both stent and stent grafts. Forked stents are not covered by this standard. Also, non-circular cross-section or conical stents are not covered by this standard.
The purpose of the tests performed under this standard is to determine the load and deformation characteristics of the stent while applying a circumferentially uniform radial load. During the test, the stent is compressed using a uniform compression ratio, starting with a diameter equal to the specified maximum vessel diameter. The load and associated diameter are recorded as you compress the stent until a significant reduction in strength occurs or a diameter reduction of at least 50 percent is reached.
For the purposes of this standard, the term balloon-expandable stent refers to a stent that is expanded by a balloon catheter at the treatment site. The stent material plastically deforms as the balloon expands, leaving the stent expanded after balloon deflation. The term self-expanding stent refers to a stent that, when released from the application system, expands to a size and shape close to the desired final size and shape without the application of external forces or pressure. The term radial pressure refers to the area-normalized output of radial loading equal to the average pressure applied to the stent by the loading fixture in the radial direction toward the stent's cylindrical axis. The term radial force refers to the radial loading output equal to radial pressure multiplied by the stent's cylindrical area.
Our organization also provides standard testing services for radial loading of balloon expandable and self-expanding vascular stents within the scope of ASTM F3067-14 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors. .
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