All interested parties are welcome to join in the development of a proposed new ASTM International standard that will provide guidance on how to conduct axial, bending, and torsional fatigue testing of stents. The proposed new standard, ASTM WK23330, Guide for in vitro Axial, Bending and Torsional Durability Testing of Vascular Stents, is being developed by the Subcommittee on Cardiovascular Standards, part of the ASTM International Committee on Medical and Surgical Materials and Devices.
The testing described in the standard will be used to support the acceptable fatigue resistance of stents for clinical use in the vasculature. The standard will also enable regulatory bodies to make better assessment of the adequacy of the testing conducted. Once approved, the proposed standard will be used by medical device manufacturers, testing laboratories, and various regulatory bodies.
The subcommittee is seeking participation from medical device manufacturers and academics working with vascular stent testing. The subcommittee’s standards developing activities include plans to work on guides for radial loading, sample size, fatigue to fracture, and absorbable stents.
ASTM International welcomes participation in the development of its standards.
