YY/T 0959-2014Spinal implants—Test methods for mechanical property of intervertebral body fusion devices (English PDF)

Foreword

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

The standard reference method using redrafted ASTM F2077-03 "interbody fusion test method" establishment.

Information on normative references, this standard has been adjusted technical differences, in order to adapt our technical conditions, adjust the set As reflected in Chapter 2, "Normative references", the specific adjustments are as follows.

- with the GB/T 16825.1 instead ASTM E4;

- with the GB/T 10623 instead ASTM E6; Technical differences between this standard and ASTM F2077-03 follows.

--- Deleted the Chapter 11 "precision and bias";

--- Deleted the Chapter 12, "keyword";

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

1 Scope

This standard specifies the static and dynamic test is used to promote a particular spinal segment fusion interbody fusion device, including the test timber Materials and methods.

This standard is intended for non-mechanical properties of biological interbody fusion contrast to establish basic principles. This test method can be used to compare with Mechanical properties in different locations and spine interbody fusion using different methods. This standard can be used in the mechanical properties of intervertebral fusion device Contrast, but it does not provide performance standards.

This standard specifies the static and dynamic testing device, specifies the type of loading and loading methods. The test device may be used for intervertebral Comparative evaluation of the fusion device. This standard does not involve the fusion cage prolapse test.

This standard was established to measure the displacement, determine the yield strength or torque, evaluation interbody fusion stiffness and strength guidelines.

Some interbody fusion device may not be suitable for testing in this standard test methods in all.

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).

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.

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.

GB/T 10623 test the mechanical properties of metallic materials terminology (GB/T 10623-2008, ISO 23718:2007, MOD)

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)

ASTM E1823 standard terminology related to fatigue and crack test (Terminologyrelatingtofatigueandfracture testing) ASTM F1582 and spinal implant-related terms (Terminologyrelatingtospinalimplants)

3 Terms and Definitions

The following terms and definitions apply to this document.