1.1 本规范和测试方法旨在为用于骨骼系统外科内固定的骨板提供全面参考。该标准建立了一致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；以及测量性能相关机械特性的标准试验方法，这些机械特性对 体内 骨板的性能。 1.2 该标准无意定义骨板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后果或其在个体患者日常生活特定活动中的使用。 此外，本标准无意描述或规定用于骨骼系统外科内固定的骨板的具体设计。 1.3 本文件可能不适用于所有类型的接骨板。鉴于特定骨板及其潜在应用，用户应注意考虑标准的适当性。 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 和 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 本标准包括多种试验方法。然而，必须注意的是，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和健康实践，并确定监管限制的适用性。 ====意义和用途====== A2.5 意义和用途 A2.5.1 该试验方法建立了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。该试验方法可用于确定在特定最大弯矩或在一系列最大弯矩条件下骨板的疲劳寿命。或者，该试验方法可用于估计骨板在指定疲劳循环次数下的疲劳强度。 A2.5.2 该测试方法使用了一个简化的骨板载荷模型，该模型可能无法准确代表原位载荷配置。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。该测试方法产生的数据可用于对不同的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应用。鉴于正在测试的设备及其潜在应用，提醒用户考虑该方法的适当性。 A2.5.4 本试验方法假设骨板由具有线弹性材料特性的材料制成。因此，该方法不适用于测试由具有非线性弹性行为的材料制成的骨板。 A2.5.5 本试验方法仅限于测试耳内的骨板- 材料的弹性范围。因此，本试验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 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 or 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== 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 can not 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 non-linear elastic behavior. A2.5.5 This test method is restricted to the testing of bone plates within the lnear-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.