YY/T 0959-2014 in English
VALIDSpinal implants―Test methods for mechanical property of intervertebral body fusion devices
- Issued on:2014-06-17
- Implemented on:2015-07-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$243.00
本标准适用于椎间融合器力学性能的对比。
本标准规定了用于促进某一特定脊柱节段融合的椎间融合器的静态和动态试验,包括试验所用材料和方法以及静态和动态试验装置,具体规定了载荷类型和加载方法。
本标准不适用于椎间融合器的脱出试验,某些椎间融合器可能不适用标准中的所有试验方法。
Scope
This standard specifies the static and dynamic testing of interbody cages used to promote fusion of a specific spinal segment, including the materials and methods used in the testing. The purpose of this standard is to establish basic principles for comparing the mechanical properties of non-biological interbody cages. This test method can be used to compare the mechanical properties of intervertebral fusion cages used in different positions of the spine and using different methods of use. This standard can be used to compare the mechanical properties of intervertebral cages, but does not provide performance standards. This standard specifies static and dynamic test devices, specifying load types and loading methods. This test device can be used for comparative evaluation of intervertebral cages. This standard does not involve prolapse testing of intervertebral cages. This standard establishes guidelines for measuring displacement, determining yield strength or torque, and evaluating the stiffness and strength of interbody cages. Some interbody cages may not be suitable for testing according to all test methods in this standard. 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). 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.

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