1.1 本规范和测试方法旨在为骨骼系统手术内固定中使用的金属骨板提供全面的参考。该标准建立了统一的方法来分类和定义骨板的几何和性能特征。该标准还提供了一份标准规范目录，其中规定了材料、标签和搬运要求，以及测量与性能相关的机械特性的标准测试方法，这些特性被确定为对 体内 骨板的性能。 1.2 本标准无意定义绩效或案例水平- 骨板的具体临床性能，因为没有足够的知识来预测其在个体患者日常生活特定活动中的使用后果。此外，本标准无意描述或指定骨骼系统手术内固定中使用的骨板的具体设计。 1.3 本文档可能不适用于所有类型的骨板。使用者应根据特定骨板及其潜在应用考虑该标准的适用性。 1.4 本文件包括用于确定以下骨板机械性能特征的以下测试方法: 1.4.1 金属骨板单循环弯曲试验的标准试验方法-- 附件A1 ，以及 1.4.2 测定金属骨板弯曲疲劳性能的标准试验方法-- 附件A2 . 1.5 以国际单位制表示的值应被视为标准值。本标准不包括其他计量单位。 1.6 本标准包含多种测试方法。但是，必须指出的是，用户没有义务使用所有描述的方法进行测试。相反，用户应该只选择适合特定设备设计的测试方法。 在大多数情况下，只需要本文所述测试方法的一个子集。 1.7 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 =====意义和用途====== A2.5 意义和用途 A2.5.1 该试验方法建立了一个统一的四点弯曲疲劳试验，以表征和比较不同骨板设计的疲劳性能。该测试方法可用于确定骨板在特定最大弯矩下或在一系列最大弯矩条件下的疲劳寿命。或者，该测试方法可用于估算骨板在指定疲劳循环次数下的疲劳强度。 A2.5.2 该测试方法利用了一个简化的骨板载荷模型，该模型可能不能准确代表 现场 加载配置。用户应注意，此测试方法生成的测试结果不能用于直接预测 体内 测试骨板的性能。该测试方法生成的数据可用于对不同骨板设计进行相对比较。 A2.5.3 该测试方法可能不适用于所有类型的植入物应用。用户应根据所测试的设备及其潜在应用考虑该方法的适当性。 A2.5.4 该测试方法假设骨板由表现出线性- 弹性材料行为。因此，该方法不适用于测试由表现出非线性弹性行为的材料制成的骨板。 A2.5.5 该测试方法仅限于测试材料线弹性范围内的骨板。因此，该测试方法不适用于在接近或超过被测骨板弯曲强度的条件下测试骨板。

1.1 This specification and test method is intended to provide a comprehensive reference for metallic bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material, labeling and handling requirements, and standard test methods for measuring performance-related mechanical characteristics determined to be important to the in vivo performance of bone plates. 1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system. 1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application. 1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics: 1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates— Annex A1 , and 1.4.2 Standard Test Method for Determining the Bending Fatigue Properties Of Metallic Bone Plates— Annex A2 . 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 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.7 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. 1.8 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 ====== A2.5 Significance and Use A2.5.1 This test method establishes a uniform four-point bending fatigue test to characterize and compare the fatigue performance of different bone plate designs. This test method may be used to determine a fatigue life of the bone plate at either a specific maximum bending moment or over a range of maximum bending moment conditions. Alternatively, the test method may be used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles. A2.5.2 This test method utilizes a simplified bone plate load model that may not be exactly representative of the in situ loading configuration. The user should note that the test results generated by this test method cannot be used to directly predict the in vivo performance of the bone plate being tested. The data generated from this test method can be used to conduct relative comparisons of different bone plate designs. A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application. A2.5.4 This test method assumes that the bone plate is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the method is not applicable for testing bone plates made from materials that exhibit nonlinear elastic behavior. A2.5.5 This test method is restricted to the testing of bone plates within the linear-elastic range of the material. Therefore, the test method is not applicable for testing bone plates under conditions that would approach or exceed the bending strength of the bone plate being tested.