ASTM International - ASTM F2079-02
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
|Publication Date:||10 May 2002|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
significance And Use:
Minimal stent recoil is a desirable feature of a stent because it minimizes the maximum diameter to which a stent must be expanded to achieve its final relaxed diameter. A stent having a high... View More
Minimal stent recoil is a desirable feature of a stent because it minimizes the maximum diameter to which a stent must be expanded to achieve its final relaxed diameter. A stent having a high recoil must be expanded to a greater diameter to achieve its final relaxed diameter than a stent having low recoil. Practically, excessive expansion of the vessel into which the stent is to be implanted may cause tissue damage resulting in a poor immediate result or poor long-term outcome. Stent recoil is affected by intrinsic properties of the material used to construct the stent and the specific geometric design of the stent; therefore, measuring stent recoil is an essential part of evaluating the design.View Less
1.1 The purpose of this test is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test is appropriate for stents manufactured from a material that is plastically deformed when the stent's diameter is increased from its predeployed size to its postdeployed size by mechanical means. This test may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.