YY/T 0857-2011Standard test methods for spinal implant constructs in a vertebrectomy model (English PDF)

Foreword

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

The standard reference method using redrafted ASTM F1717-10 "corpectomy spinal implant model test method" establishment. Technical differences between this standard and ASTM F1717-10 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 the GB/T 19701.2 instead ASTM D638;

- GB/T 10623 instead ASTM E6 and ASTM E1150;

- replaced with JJG 139 ASTM E4;

- delete ASTM E177 and ASTM E691 references.

--- Deleted the Chapter 11 "Keyword." --- Removed Tables 1 to 10 and the criteria in relevant inter-laboratory comparison content.

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

--- The Appendix X2 to Appendix B, remains unchanged.

1 Scope

This standard specifies the vertebral body resection model spinal implant assembly materials and methods were static and fatigue tests. Most spinal implant Test material components in combination depending on the intended site of spinal implants and application methods. These test methods are designed to past, present and future Mechanical properties of spinal implant components provide the basis for comparison, it is expected to allow for the application site and application of different methods of spinal implant structure Compare. These test methods is not intended to define the level of performance, because there is not enough information to predict some of the implant using a junction fruit. These test methods provide guidance for the type of load and the load method, spinal implant assembly provides for three static comparative evaluation Test method and a fatigue test methods. These test methods to measure the displacement, and the assessment of yield load determined spinal implant component Stiffness and strength to establish a principle. Some structures may not be tested in all experimental models. This standard uses the International System of Units.

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 administrative limit, this is the standard user's 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 term

GB/T 19701.2 surgical implants ultrahigh molecular weight polyethylene - Part 2. molded plastic (ISO 5834-2)

JJG 139 tension, pressure, and universal testing machine Statistical analysis lifetime (epsilon-N) Fatigue Data - ASTM E739 linear or linearized stress - life (SN) and strain (Practiceforstatisticalanalysisoflinearorlinearizedstress-life (SN) andstrain-life (epsilon-N) fatiguedata) ASTM F1582 and spinal implant-related terms (Terminologyrelatingtospinalimplants) ASTM F2077 interbody fusion test methods (Testmethodsforintervertebralbodyfusiondevices)

3 Terms and Definitions

ASTM F1582, GB/T 10623 and as defined in the following terms and definitions apply to this document.