YY/T 0960-2014Spinal implants—Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression (English PDF)

Foreword

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

The standard reference method using redrafted using "Standard Test Method for interbody fusion static axial compression subsidence" ASTM F2267-04 prepared by. Technical differences between this standard and ASTM F2267-04 follows.

--- On normative references, this standard has been adjusted technical differences, in order to adapt our technical conditions, the adjusted situation Focus is reflected in the status of Chapter 2, "Normative references", the specific adjustments are as follows.

- with GB/T 16825.1 instead ASTM E4;

--- Deleted the Chapter 10, "Precision and Bias";

--- Deleted the Chapter 11 "Keyword";

--- In Appendix X1 to Appendix A, remains unchanged.

1 Scope

The standard provides for the promotion of non-biological fusion cage axially a specific spinal segment fusion compression subsidence test material used Materials and methods.

This standard is used to compare the mechanical properties of intervertebral fusion cage Interbody Fusion rather than provide performance standards designed to contrast abiotic vertebral Fusion between the mechanical properties of the establishment of basic principles.

This standard specifies a static test method specifies the type of loading and loading methods. This test method can be used for interbody fusion Comparative evaluation of the clutch.

This standard has been established test pieces measuring deformation and determine interbody fusion cage subsidence guidelines.

The standard unit of angle measurement in addition to the possibility of using degrees or radians, the other measurements using the International System of Units (SI).

Some require the use of additional interbody fusion implants to improve the stability, and therefore may not be in accordance with the manufacturer's recommended method to test Such implants.

This standard does not attempt to all the security issues involved elaborate, even those safety issues associated with their use. establish Appropriate safety and health practices and suitability before applying clear management restrictions, the user of this standard is its own responsibility. Appendix A of this standard gives the basic principles.

2 Normative references

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

Inspection and correction tension and (or) pressure testing machine force measuring system. GB/T 16825.1 of static uniaxial testing machines - Part 1 Associate (GB/T 16825.1-2008, ISO 7500-1:2004, IDT)

Interbody fusion material mechanical properties test methods YY/T 0959 spinal implant ASTM F1582 and spinal implant-related terms (Terminologyrelatingtospinalimplants)

ASTM F1839 orthopedic instruments and tools for testing standard material rigid polyurethane foam (Specificationforrigidpolyu-rethanefoamforuseasastandardmaterialfortestingorthopaedicdevicesandinstruments)

3 Terms and Definitions

The following terms and definitions apply to this document.