1.1 本规范提供了外骨骼固定装置（ESFD）设计和机械功能的表征，ESFD机械性能表征的测试方法，并确定了进一步开发测试方法和性能标准的需求。最终目标是制定一项规范，该规范定义了ESFD及其骨固定的性能相关力学特性测量的性能标准和方法。本规范无意定义性能或案例的级别- 设备的具体临床性能，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。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；材料规范；性能定义；试验方法； 以及确定对 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五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- 附录A6 . 1.3.7 外骨骼固定器/构件子组件的试验方法- 附件A7 . 1.4 基本原理见 附录X1 . 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 以下安全隐患警告仅适用于试验方法部分( 附录A2– 附录A6 ): 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====== A1.4 意义和用途 A1.4.1 该分类的目的是建立一个一致的术语系统，通过该系统可以对这些ESFD配置进行分类。预计随后将开发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 five 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 The following safety hazards caveat pertains only to the test method portions ( Annex A2 – Annex A6 ): 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 ====== 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.