Press Release Summary:
Medical device manufacturers and academics working with vascular stent testing are welcome to join in developing proposed new ASTM International standard ASTM WK23330, Guide for in Vitro Axial, Bending and Torsional Durability Testing of Vascular Stents. Testing described therein will be used to support acceptable fatigue resistance of stents for clinical use in vasculature as well as to enable regulatory bodies to better assess adequacy of testing conducted.
Original Press Release:
Proposed Vascular Stent Standard Being Developed by ASTM International Surgical Materials Committee
W. CONSHOHOCKEN, Pa.—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 Subcommittee F04.30 on Cardiovascular Standards, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.
“Non-radial arterial motions of stents from musculoskeletal activities, such as walking and breathing, and cardiac motion, have been identified to be important in many arteries, for example, SFA, renal, carotid and coronary, however there are no standards on how to conduct such testing,” says Brian Choules, director, nonclinical testing, MED Institute Inc., and chair of F04.30.
According to Choules, the testing described in the ASTM WK23330 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.
Subcommittee F04.30 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. For more information on becoming an ASTM member, visit www.astm.org/JOIN.
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ASTM Task Group F04.30.06 Next Meeting: Nov. 21, 2013, FDA White Oak Campus, Silver Spring, Md.
Technical Contact: Brian Choules, MED Institute Inc., West Lafayette, Ind., Phone: 765-463-7537; firstname.lastname@example.org
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