1. Scope
1.1 The purpose of this test method 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
method 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 method 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.