1.1 本规范旨在提供髓内固定装置（IMFD）的设计和机械功能特征，规定标签和材料要求，提供IMFD机械性能特征的测试方法，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IMFD及其骨固定性能相关机械特性的性能标准和测量方法。本规范的目的不是定义这些设备的性能水平或特定病例的临床性能，因为目前还没有足够的知识来预测在个体患者中使用这些设备进行特定日常生活活动的后果。 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；标签和材料规格；绩效定义；试验方法；以及被确定为重要的特征 体内 设备的性能。 1.3 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。 1.4 本规范包括四种标准测试方法: 1.4.1 静态四点弯曲试验方法-- 附件A1 . 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 理论基础见 附录X1 . 1.6 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。 1.7 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====== A1.4 意义和用途 A1.4.1 本试验方法描述了一种静态弯曲试验，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物应用（即存在螺钉孔的IMFD近端或远端）。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。

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 . 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. 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 ====== 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 (that is, 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.