1.1 本规范旨在描述髓内固定装置（IMFD）的设计和机械功能，规定标签和材料要求，提供表征IMFD机械性能的测试方法，并确定进一步开发测试方法和性能标准的需求。最终目标是制定一个标准，定义用于测量IMFD及其骨固定的性能相关力学特性的性能标准和方法。本规范无意定义这些设备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患者在日常生活的特定活动中使用这些设备的后果。 本规范无意描述或指定IMFD的具体设计。 1.2 本规范描述了用于骨骼系统手术固定的IMFD。它提供了基本的IMFD几何定义、尺寸、分类和术语；标签和材料规范；性能定义；测试方法和特性对 体内 设备的性能。 1.3 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。 1.4 本规范包括四种标准试验方法: 1.4.1 静态四点弯曲试验方法- 附件A1 和 1.4.2 静态扭转试验方法- 附件A2 . 1.4.3 弯曲疲劳试验方法- 附件A3 . 1.4.4 IMFD锁紧螺钉弯曲疲劳试验方法- 附件A4 . 1.5 基本原理见 附录X1 . 1.6 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。 ====意义和用途====== A1.4 意义和用途 A1.4.1 本试验方法描述了静态弯曲试验，以确定IMFD中心和均匀部分的弯曲刚度和弯曲强度。 A1.4.2 该测试方法可能不适用于所有类型的植入应用（即，在存在螺钉孔的IMFD的近端或远端）。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。

1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs. 1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device. 1.3 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. 1.4 This specification includes four standard test methods: 1.4.1 Static Four-Point Bend Test Method— Annex A1 and 1.4.2 Static Torsion Test Method— Annex A2 . 1.4.3 Bending Fatigue Test Method— Annex A3 . 1.4.4 Test Method for Bending Fatigue of IMFD Locking Screws— Annex A4 . 1.5 A rationale is given in Appendix X1 . 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. ====== Significance And Use ====== A1.4 Significance and Use A1.4.1 This test method describes a static bending test to determine the bending stiffness and bending strength of the central and uniform portions of an IMFD. A1.4.2 This test method may not be appropriate for all types of implant applications (i.e., in proximal or distal extremity of an IMFD where screw holes exist). The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential applications.