1.1 本试验方法包括通过小型圆盘试样（厚度0.5 mm，直径6.4 mm）的小冲孔试验测定聚合物生物材料的力学行为。已经建立了用于表征冲压挤压或压缩成型后的手术材料的测试方法 ( 1- 3. ) 2. ; 用于评估制造植入物和灭菌方法的效果 ( 4. , 5. ) ; 以及测试从人体中取出（移植）的植入物 ( 6. , 7. ) . 1.2 小冲头试验的结果，即峰值载荷、极限位移、极限载荷和失效功，提供了多轴载荷条件下屈服、极限强度、延性和韧性的指标。 因为在单轴和多轴加载条件下加载时，力学行为可能不同 ( 8. ) 小冲头试验为单轴拉伸试验提供了一种补充的机械试验技术。然而，应注意的是，小冲孔试验结果可能与单轴拉伸试验结果不相关。 1.3 除了用作植入物回收分析的研究工具外，小冲孔试验还可以用作实验室筛选试验，以评估材料浪费最少的新材料 ( 1. ) . 1.4 小冲击试验已应用于其他聚合物，包括聚甲基丙烯酸甲酯（PMMA）骨水泥、聚甲醛和高密度聚乙烯（HDPE）、超高分子量聚乙烯（UHMWPE）和聚醚醚酮（PEEK） ( 2. , 3. , 5. , 9 , 10 ) . 本标准概述了可植入聚合物小穿孔测试的一般指南。 1.5 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。 1.6 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 微型试样测试技术用于表征聚合物储备材料和外科植入物在制造、灭菌、货架老化、辐射交联、热处理、填料掺入和植入后的力学行为 ( 1- 3. ) . 此外，可以在加速老化、疲劳试验和髋部、膝盖或脊椎磨损模拟后对实验材料进行评估。因此，小冲头试验可以检查磨损性能和机械性能之间的关系。该试验方法也可用于对相对于参考对照材料的机械行为进行排序。 4.2 小冲头测试结果可能因试样制备、测试速度和环境而异。因此，如果需要精确的比较结果，则必须仔细控制这些因素。

1.1 This test method covers the determination of mechanical behavior of polymeric biomaterials by small punch testing of miniature disk specimens (0.5 mm in thickness and 6.4 mm in diameter). The test method has been established for characterizing surgical materials after ram extrusion or compression molding ( 1- 3 ) 2 ; for evaluating as-manufactured implants and sterilization method effects ( 4 , 5 ) ; as well as for testing of implants that have been retrieved (explanted) from the human body ( 6 , 7 ) . 1.2 The results of the small punch test, namely the peak load, ultimate displacement, ultimate load, and work to failure, provide metrics of the yielding, ultimate strength, ductility, and toughness under multiaxial loading conditions. Because the mechanical behavior can be different when loaded under uniaxial and multiaxial loading conditions ( 8 ) , the small punch test provides a complementary mechanical testing technique to the uniaxial tensile test. However, it should be noted that the small punch test results may not correlate with uniaxial tensile test results. 1.3 In addition to its use as a research tool in implant retrieval analysis, the small punch test can be used as a laboratory screening test to evaluate new materials with minimal material waste ( 1 ) . 1.4 The small punch test has been applied to other polymers, including polymethyl methacrylate (PMMA) bone cement, polyacetal, and high density polyethylene (HDPE), ultra high molecular weight polyethylene (UHMWPE), and polyetheretherketone (PEEK) ( 2 , 3 , 5 , 9 , 10 ) . This standard outlines general guidelines for the small punch testing of implantable polymers. 1.5 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. 1.6 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 Miniature specimen testing techniques are used to characterize the mechanical behavior of polymer stock materials and surgical implants after manufacture, sterilization, shelf aging, radiation crosslinking, thermal treatment, filler incorporation, and implantation ( 1- 3 ) . Furthermore, experimental materials can be evaluated after accelerated aging, fatigue testing, and hip, knee, or spine wear simulation. Consequently, the small punch test makes it possible to examine relationships between wear performance and mechanical behavior. This test method can also be used to rank the mechanical behavior relative to a reference control material. 4.2 Small punch testing results may vary with specimen preparation and with the speed and environment of testing. Consequently, where precise comparative results are desired, these factors must be carefully controlled.