YY/T 0961-2014Standard guide for evaluating the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants (English PDF)

Foreword

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

This standard uses redrafted fixed system components and connections within the law Reference ASTM F1798-2008 "spinal implant spinal device Static and Fatigue Evaluation Method opposed to "establishment. Technical differences between this standard and ASTM F1798-2008 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;

- ASTM F382 delete references;

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

--- Chapter 12 will be adjusted as Appendix A;

--- Deleted the Chapter 13 "key words." Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.

1 Scope

This standard specifies the test method for loosening of spinal fixation system uniaxial static and fatigue strength as well as anti-assembly connecting means. The standard Evaluation criteria are intended to provide a method for the mechanical properties of different designs of the spinal implant connection device. Different components and connecting devices shall be combined into a ridge Column implant static and fatigue test structure. The purpose of these test methods is not to analyze overall and local structure spinal implants, nor is it Define its performance level, because there is not enough information to predict the results of the use of a design of the implant. This standard lists the test spine The implant assembly connection definition means strength, reporting a possible test methods and results.

In addition to measuring angles in degrees or radians units, the standard SI 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.

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 F1582 and spinal implant-related terms (Terminologyrelatingtospinalimplants)

3 Terms and Definitions

The following terms and definitions apply to this document.