YY/T 1560-2017Spinal implant—Standard test methods for occipital-cervical and occipital-cervical-thoracic implant constructs in a vertebrectomy model (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the materials and methods of static and fatigue tests of the occipitocervix and occipito-cervical implant components in a vertebral body excision model. most The test material for the occipitoccipital and occipito-cervical implant components depends on the intended site of implantation and the method of application.

This test method is intended to provide a basis for the comparison of the mechanical properties of occipitoccipital and occipito-cervical implant components in the past, present and future, The method can be used to compare the occipito-cervical and occipito-cervical thoracic implants that are expected for different application sites and methods of application. The purpose of these test methods It is not intended to define the performance level as there is not enough information to predict the outcome of an implant.

This standard provides guidelines for loading types and loading methods and provides for the comparative evaluation of occipitoccipital and occipito-cervical implant components three Static test methods and two fatigue test methods. This test method is to measure the displacement, determine the yield load and evaluate the occipital or occipitocervix The rigidity and strength of the implant assembly establish the guiding principle. Some occipito-cervical or occipito-cervical implants may not be suitable for use in accordance with this standard Test configuration for testing.

This standard is not intended to address all the safety issues involved, even those related to their use safety issues. establish Appropriate safety and health practices, as well as the applicability of a clear management limit before application, are the sole responsibility of the user of this standard.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 16825.1 static uniaxial testing machine test Part 1. Tensile and (or) pressure testing machine testing system and force measurement calibration

YY/T 0857 vertebral excision model of spinal implant test methods Spinal implant interbody fusion cage mechanical properties test method

3 Terms and definitions

The following terms and definitions apply to this document.