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现行 ASTM F2079-09(2022)
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Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents 测量气球可膨胀支架固有弹性反冲的标准试验方法
发布日期: 2022-10-01
1.1 本试验方法的目的是量化支架直径从扩张直径减小到放气后松弛直径的百分比。本试验方法适用于由一种材料制成的支架,当支架直径通过机械方式从预部署尺寸增加到部署后尺寸时,该材料会发生塑性变形。该试验方法可在室温下的空气中进行,除非材料具有已知的温度依赖性,在这种情况下,应在报告中说明进行试验的温度。 1.2 以国际单位表示的数值视为标准值。本标准不包括其他计量单位。 1.3 本标准并不旨在解决与其使用相关的所有安全问题(如有)。 本标准的使用者有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 4.1 最小支架反冲是支架的一个理想特征,因为它使支架必须扩张到的最大直径最小,以达到其最终松弛直径。与低反冲支架相比,具有高反冲的支架必须扩大到更大的直径,以实现其最终松弛直径。 实际上,支架植入血管的过度扩张可能会导致组织损伤,导致近期效果不佳或长期效果不佳。支架反冲受支架材料的固有特性和支架的特定几何设计的影响;因此,测量支架后坐力是评估设计的重要部分。
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. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 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.
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归口单位: F04.30
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