YY/T 0961-2014 in English

本标准适用于脊柱内固定系统。
本标准规定了脊柱内固定系统单轴静态及疲劳强度以及组件连接装置抗松动性的试验方法。

Scope

This standard specifies the test methods for the uniaxial static and fatigue strength of spinal internal fixation systems and the resistance to loosening of component connections. This standard aims to provide mechanical performance evaluation methods for spinal implant connection devices of different designs. Different components and connecting devices should be combined into static and fatigue test structures of spinal implants. The purpose of these test methods is not to analyze the global and local structure of spinal implants, nor to define their performance levels, because there is not enough information to predict the results of using a certain design of implant. This standard sets out definitions for testing the strength of connecting devices of spinal implant components, possible test methods, and reporting of results. This standard uses the International System of Units, except that angles are measured in degrees or radians. This standard does not attempt to address all safety issues involved, even those relevant to its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to clarify the applicability of regulatory limitations before application.