1.1 这些规范和测试方法为骨骼系统手术内固定中使用的成角度装置提供了全面的参考。本标准建立了统一的方法来分类和定义倾斜设备的几何和性能特征。本标准还提供了一个标准规范目录，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，这些特性对 体内 倾斜设备的性能。 1.2 本标准的目的不是定义斜角装置的性能水平或特定病例的临床性能，因为没有足够的知识来预测它们在个体患者日常生活特定活动中的使用后果。 此外，本标准没有描述或规定骨骼系统手术内固定中使用的成角度装置的具体设计。 1.3 本标准可能不适用于所有类型的倾斜设备。鉴于特定角度的设备及其潜在应用，用户应考虑本标准的适用性。 注1: 本标准不适用于无侧板的髓内髋螺钉钉或其他成角度装置。 1.4 本标准包括以下用于确定以下倾斜装置机械性能特征的测试方法: 1.4.1 金属成角骨科骨折固定装置单循环压缩弯曲试验的标准试验方法（见 附件A1 ). 1.4.2 测定金属成角骨科骨折固定装置弯曲疲劳性能的标准试验方法（见 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。 注2: 目前还没有与该标准相似或等效的ISO标准。 1.6 本标准包含多种测试方法。然而，用户不一定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，并给出理由。这可能只是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均匀的悬臂弯曲疲劳试验，以表征和比较不同角度装置设计的疲劳性能。 该试验方法可用于确定倾斜装置在特定或最大弯矩条件下的疲劳寿命。此外，该测试方法也可用于估算倾斜装置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成角度装置悬臂弯曲载荷模型，该模型可能无法准确代表 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 被测试的倾斜装置的性能。该测试方法生成的数据可用于对不同角度的设备设计进行相对比较。 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 该测试方法假设倾斜装置由表现出线性弹性材料行为的材料制成；因此，该测试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倾斜装置。 A2.5.5 该测试方法仅限于测试材料线弹性范围内的倾斜装置；因此，该测试方法不适用于在接近或超过被测倾斜装置弯曲强度的条件下测试倾斜装置。

1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This 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 angled devices. 1.2 It is not the intention of this standard to define levels of performance or case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Furthermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system. 1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application. Note 1: This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate. 1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics: 1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1 ). 1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see 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. Note 2: There is currently no ISO standard that is either similar or equivalent to this standard. 1.6 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods. 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 The test method establishes a uniform cantilever bending fatigue test to characterize and compare the fatigue performance of different angled device designs. This test method may be used to determine the fatigue life of an angled device at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate the fatigue strength of an angled device for a specified number of fatigue cycles. A2.5.2 The test method utilizes a simplified angled device cantilever bending 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 angled device being tested. The data generated from this test method can be used to conduct relative comparisons of different angled device 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 angled device is manufactured from a material that exhibits linear-elastic material behavior; therefore, this test method is not applicable for testing angled devices made from materials that exhibit nonlinear elastic behavior. A2.5.5 This test method is restricted to the testing of angled devices within the linear-elastic range of the material; therefore, this test method is not applicable for testing angled devices under conditions that would approach or exceed the bending strength of the angled device being tested.