YY/T 0591-2011 in English

本标准规定了金属带锁髓内钉)的设计特征和力学性能,规定了基本几何定义、尺寸、分类、术语、材料、表面处理、灭菌、包装和制造商提供的
信息的要求,提供了表征带锁髓内钉力学性能的试验方法,确定了继续改进试验方法和性能标准的必要性。
本标准的最终目的是定义带锁髓内钉性能标准和与性能相关的力学性能及其与骨相固定的试验方法。由于没有足够的知识,尚无法预测带锁髓内钉在个体患者日常生活中特殊活动的使用结果。本标准的目的并不是定义带锁髓内钉的性能等级或具体病例的临床性能,同时本标准也未描述或规范带锁
髓内钉的特殊设计。
本标准描述了骨骼系统外科固定用带锁髓内钉。提供了带锁髓内钉的基本几何定义、尺寸、分类和
术语、标签和材料标准、性能定义及带锁髓内钉在体内与使用相关重要性能的试验和表征方法。
本标准包括了4个标准试验方法:
———静态四点弯曲试验方法(附录A);
———带锁髓内钉的静态扭转试验方法(附录B);
———带锁髓内钉弯曲疲劳试验方法(附录C);
———带锁髓内钉锁定螺钉的弯曲疲劳试验方法(附录D)。
附录E中给出基本原理。
本标准采用国际单位制(SI)

Scope

This standard specifies the design characteristics and mechanical properties of metal lockable intramedullary nails (hereinafter referred to as locking intramedullary nails), and specifies basic geometric definitions, dimensions, classification, terminology, materials, surface treatment, sterilization , packaging, and requirements for information provided by manufacturers, provide test methods for characterizing the mechanical properties of locking intramedullary nails, and identify the need for continued improvement of test methods and performance standards. The ultimate purpose of this standard is to define the performance standards and test methods for performance-related mechanical properties and bone fixation of locking intramedullary nails. Because insufficient knowledge is not available, it is not possible to predict the outcome of the use of locked intramedullary nails in individual patients for specific activities of daily living. The purpose of this standard is not to define the performance level or clinical performance of locking intramedullary nails in specific cases, nor does this standard describe or regulate the specific design of locking intramedullary nails. This standard describes locking intramedullary nails for surgical fixation of the skeletal system. Provides basic geometric definitions, dimensions, classification and terminology, labeling and material standards, performance definitions, and testing and characterization methods of important properties of locking intramedullary nails in vivo and related to use. This standard includes 4 standard test methods:
　——Static four-point bending test method (Appendix A);
　——Static torsion test method of locking intramedullary nails (Appendix B);
　——Bending fatigue test of locking intramedullary nails Method (Appendix C);
　——Bending fatigue test method of locking intramedullary nail locking screws (Appendix D). The rationale is given in Appendix E. This standard uses the International System of Units (SI).