YY/T 1647-2019Joint replacement implants - Shoulder prostheses - Standard test method for static evaluation of glenoid locking mechanism in shear (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 test method for the static shear separation force of combined glenoid components in shoulder joint prostheses. Combined glenoid component A separate glenoid lining and glenoid backing should be included. The glenoid lining and glenoid backing can be made from any combination of the following materials. Metal alloys, polymeric materials and composites.

This standard applies to product design verification and comparison with other prostheses.

Note. See Appendix A for test principles.

2 Normative references

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

GB/T 16825.1 Inspection of static uniaxial testing machines Part 1. Inspection and testing of force measurement system of tensile and/or compression testing machines calibration

YY/T 0963 Joint replacement implant shoulder joint prosthesis

3 Terms and definitions

The following terms and definitions apply to this document.

4 Significance and application

4.1 The glenoid component is generally used for shoulder joint replacement and should meet the requirements of YY/T 0963.

4.2 This standard can be used to describe the resistance of the material, processing technology and design factors to the locking mechanism of a glenoid prosthesis with a metal backing.

Effect of static shear loading. In view of the fact that the glenoid prosthesis usually with a metal backing is different from the force in this body, The results obtained by this standard cannot be directly used to predict the performance of the product in vivo. However, this standard can be used for different test conditions under similar test conditions. Comparison of Locking Mechanism Designs of Metal-Backed Glenoid Parts.

4.3 This standard does not necessarily apply to all types of implant applications. Users of this standard should consider the test materials and their intended use. Consider the applicability of this standard.