1.1 本试验方法描述了评估丙烯酸骨水泥材料恒幅、单轴、拉-压均匀疲劳性能的试验程序。 1.2 本试验方法适用于规范中规定的基于丙烯酸树脂的骨科骨水泥 F451 和ISO 16402。本试验方法中的程序可能适用于也可能不适用于其他外科水泥材料。 1.3 本试验方法的目的不是定义这些材料的性能水平。本试验方法的目的不是直接模拟这些材料的临床应用，而是允许比较丙烯酸骨水泥，以评估特定条件下的疲劳行为。 1.4 基本原理见 附录X2 . 1.5 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户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。 1.7 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====== 5.1 本试验方法描述了一种单轴等幅全反向疲劳试验，以表征由丙烯酸骨水泥制成的均匀圆柱腰试样的疲劳性能。 5.2 本试验方法考虑了两种评估骨水泥疲劳性能的方法: 5.2.1 测试在三个应力水平下进行，以表征水泥在一系列应力下的一般疲劳行为。试样的应力水平和由此产生的破坏循环可以绘制在 S-N 简图 5.2.2 另一种方法是确定特定水泥的疲劳寿命。骨科骨水泥的疲劳寿命应达到500万（5×10 6. )周期。 5.3 本试验方法未定义或建议骨水泥的性能要求水平。该疲劳试验方法不代表骨科骨水泥的临床应用，而是使用标准和成熟的方法表征材料。鉴于所测试的材料及其潜在应用，提醒用户考虑本测试方法的适当性。 5.4 据广泛报道，多种临床因素影响骨科骨水泥的疲劳性能；然而，实际机制涉及多个因素。可能影响骨水泥性能的临床因素包括:温度和湿度、混合方法、应用时间、手术技术、骨准备、种植设计、解剖部位和患者因素等。该测试方法并没有具体解决所有这些临床因素。该测试方法可用于比较不同的丙烯酸骨水泥配方和产品以及不同的混合方法和环境（即混合温度、真空度、离心等）。

1.1 This test method describes test procedures for evaluating the constant amplitude, uniaxial, tension-compression uniform fatigue performance of acrylic bone cement materials. 1.2 This test method is relevant to orthopedic bone cements based on acrylic resins, as specified in Specification F451 and ISO 16402. The procedures in this test method may or may not apply to other surgical cement materials. 1.3 It is not the intention of this test method to define levels of performance of these materials. It is not the intention of this test method to directly simulate the clinical use of these materials, but rather to allow for comparison between acrylic bone cements to evaluate fatigue behavior under specified conditions. 1.4 A rationale is given in Appendix X2 . 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 ====== 5.1 This test method describes a uniaxial, constant amplitude, fully reversed fatigue test to characterize the fatigue performance of a uniform cylindrical waisted specimen manufactured from acrylic bone cement. 5.2 This test method considers two approaches to evaluating the fatigue performance of bone cement: 5.2.1 Testing is conducted at three stress levels to characterize the general fatigue behavior of a cement over a range of stresses. The stress level and resultant cycles to failure of the specimens can be plotted on an S-N diagram. 5.2.2 Another approach is to determine the fatigue life of a particular cement. The fatigue life for orthopaedic bone cement is to be determined up to 5 million (5 × 10 6 ) cycles. 5.3 This test method does not define or suggest required levels of performance of bone cement. This fatigue test method is not intended to represent the clinical use of orthopaedic bone cement, but rather to characterize the material using standard and well-established methods. The user is cautioned to consider the appropriateness of this test method in view of the material being tested and its potential application. 5.4 It is widely reported that multiple clinical factors affect the fatigue performance of orthopaedic bone cement; however, the actual mechanisms involves multiple factors. Clinical factors which may affect the performance of bone cement include: temperature and humidity, mixing method, time of application, surgical technique, bone preparation, implant design, anatomical site, and patient factors, among others. This test method does not specifically address all of these clinical factors. The test method can be used to compare different acrylic bone cement formulations and products and different mixing methods and environments (that is, mixing temperature, vacuum, centrifugation, and so forth).