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.