1.1 本规范涵盖了用于肌肉骨骼系统内固定的金属钉的设计和机械功能的特征。本规范无意描述或指定金属骨钉的具体设计。 1.2 本规范包括以下四种测试方法，用于测量金属骨钉的机械性能: 1.2.1 金属骨钉等幅弯曲疲劳试验的试验方法- 附件A1 . 1.2.2 金属骨钉拔出固定强度的试验方法- 附件A2 . 1.2.3 金属骨钉软组织固定强度的试验方法- 附件A3 . 1.2.4 金属骨钉弹性静态弯曲的试验方法- 附件A4 . 1.3 以国际单位制表示的数值应视为标准值。本标准中包含的任何其他测量单位仅供参考。 1.4 本标准包括多种试验方法。 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，用户应仅选择适用于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子集。 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====== A1.3 意义和用途 A1.3.1 本试验方法用于确定金属骨钉在承受大量循环重复载荷时的抗疲劳性。在某些情况下，该信息还可用于比较装订材料、几何形状、表面条件或放置变化的影响。 A1.3.2 为了使这些基本疲劳数据具有可比性和可再现性，并能够在实验室之间相互关联，必须建立统一的疲劳实践。 A1.3.3 只有当使用条件与试验条件完全平行时，疲劳试验结果才适合直接应用于设计。该测试方法可能不适用于所有类型的骨钉应用。鉴于所测试的材料及其潜在应用，提醒用户考虑测试方法的适当性。

1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. 1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples: 1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples— Annex A1 . 1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples— Annex A2 . 1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples— Annex A3 . 1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples— Annex A4 . 1.3 The values stated in SI units are to be regarded as standard. Any other units of measurement included in this standard are shown for reference only. 1.4 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. 1.5 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 ====== A1.3 Significance and Use A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances. A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories. A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application.