1.1 本规范提供了外骨骼固定装置（ESFD）的设计和机械功能的特征，ESFD机械性能特征的测试方法，并确定了进一步开发测试方法和性能标准的需求。最终目标是制定一份规范，定义ESFD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。 此外，本规范无意描述或指定ESFD的具体设计。 1.2 本规范描述了用于骨骼系统手术固定的ESFD。它提供了基本的ESFD几何定义、尺寸、分类和术语；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 本规范包括一个术语和分类附件以及六个标准试验方法附件，如下所示: 1.3.1 外固定器的分类-- 附件A1 . 1.3.2 外骨骼固定器连接器的试验方法-- 附件A2 . 1.3.3 测定圆环或环段桥梁构件平面内压缩性能的试验方法-- 附件A3 . 1.3.4 外骨骼固定器关节的试验方法-- 附件A4 . 1.3.5 外骨骼固定器销锚固元件的试验方法-- 附件A5 . 1.3.6 外骨骼固定器组件的试验方法-- 附件A6 . 1.3.7 外骨骼固定器/结构组件的试验方法-- 附件A7 . 1.4 理论基础见 附录X1 . 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。 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 以下安全隐患警告仅适用于测试方法部分( 附件A2 附件A6 ): 1.8 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。 1.9 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 这种分类的目的是建立一个一致的术语体系，通过该体系可以对这些ESFD配置进行分类。预计随后将制定使用该分类系统的配套测试标准。

1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs. 1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in vivo performance of the device. 1.3 This specification includes a terminology and classification annex and six standard test method annexes as follows: 1.3.1 Classification of External Fixators— Annex A1 . 1.3.2 Test Method for External Skeletal Fixator Connectors— Annex A2 . 1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements— Annex A3 . 1.3.4 Test Method for External Skeletal Fixator Joints— Annex A4 . 1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements— Annex A5 . 1.3.6 Test Method for External Skeletal Fixator Subassemblies— Annex A6 . 1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies— Annex A7 . 1.4 A rationale is given in Appendix X1 . 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, 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 The following safety hazards caveat pertains only to the test method portions ( Annex A2 – Annex A6 ): 1.8 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. 1.9 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 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed.