YY/T 0960-2014 in English

本标准规定了用于促进某一特定脊柱节段融合的非生物椎间融合器轴向压缩沉陷试验所采用的材料和方法。
本标准是用来对比椎间融合器的力学性能而非提供椎间融合器的性能标准,旨在为对比非生物椎间融合器的力学性能建立基本原则。
本标准规定了一种静态试验方法,具体规定了载荷类型和加载方法。该试验方法可以用于椎间融合器的对比性评价。
本标准已建立了测量试验块形变和确定椎间融合器沉陷的指南。
本标准中除角度测量值的单位可能采用度或弧度外,其他测量值采用国际单位(SI)。
某些椎间融合器需要使用额外植入物来提高稳定性,因此可能无法按照制造商推荐的方法来测试
该类植入物。
本标准并非试图对所涉及的所有安全问题进行阐述,即便是那些与其使用有关的安全问题。确立适当的安全及健康规范,以及在应用前明确管理限制的适用性,是本标准的使用者自身的责任。
本标准的附录A 给出了基本原理。

Scope

This standard specifies the materials and methods used for axial compression subsidence testing of non-biological interbody cages used to promote fusion of a specific spinal segment. This standard is used to compare the mechanical properties of intervertebral fusion cages rather than provide performance standards for intervertebral fusion cages. It aims to establish basic principles for comparing the mechanical properties of non-biological intervertebral cages. This standard specifies a static test method, specifying the load type and loading method. This test method can be used for comparative evaluation of intervertebral cages. This standard has established guidelines for measuring test block deformation and determining interbody cage subsidence. In this standard, except for the unit of angular measurement values, which may be in degrees or radians, other measurement values are in International Units (SI). Some interbody cages require the use of additional implants to increase stability, so it may not be possible to test such implants according to the manufacturer's recommended methods. 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. Appendix A of this standard gives the basic principles.