YY/T 0988.13-2016Coatings of surgical implants - Part 13: Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating (English PDF)

Foreword

YY/T 0988 "Surgical Implant Coating" is divided into the following sections.

- Part 1. cobalt - 28 chromium - 6 molybdenum powder;

- Part 2. Titanium and titanium - 6 - 4 - vanadium alloy powders;

- Part 3 to Part 10. (reserved);

- Part 11. Test methods for tensile test of calcium phosphate coating and metal coating;

Part 12. Test methods for calcium phosphate coating and metal coating shear test;

- Part 13. Test methods for shear and bending fatigue of calcium phosphate, metal and calcium phosphate/metal composite coatings;

- Part 14. Method for evaluation of porous coating bodies;

Part 15. Test method for abrasion resistance of metallic thermal sprayed coatings. This section is part 13 of YY/T 0988.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This section uses the re-drafting method to refer to ASTM F1160-2005 "Calcium Phosphate, Medical Metal and Calcium Phosphate/Metal Composite Coating Shear And bending fatigue test method ".

The technical differences between this part and ASTM F1160-2005 are as follows.

--- on the normative reference documents, this part has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "Normative references", as follows. Replace GBME6 with GB/T 10623;

--- "precision and deviation", "keyword".

--- change Appendix X1 to Appendix A, the same.

1 Scope

This part of YY/T 0988 contains a test to determine the shear and flex fatigue properties of calcium phosphate coatings, porous and non-porous metal coatings Method, also includes a test method for determining the bending fatigue properties of a metal coating covered with calcium phosphate. This part is based on plasma spraying Titanium coating and plasma sprayed hydroxyapatite coating. This section has not yet been established for other coatings. In shear fatigue mode This test method evaluates the adhesion and bonding properties of the coating on the coated metal substrate. This section evaluates the coating in the bending fatigue mode The adhesion and the effect of the coating on the matrix material. These test methods are carried out only at room temperature in air. The purpose of this section is not for parts Or the device for fatigue test, but this test method is preferred to the actual loading device for the most approximate simulation. This part adopts the International System of Units (SI).

This section does not attempt to address all the security issues involved, even those related to their use. Indeed It is the responsibility of this part of the user to establish appropriate safety and health practices, as well as the applicability of regulatory restrictions before application.

2 Normative reference documents

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

Test terminology for mechanical properties of metallic materials GB/T ASTM E206 Fatigue test and fatigue data Statistical analysis Definition of related terms (Definitionsoftermsrelatingto fatiguetestingandthestatisticalanlysisoffatiguedata)

ASTM E466 metal material force control constant amplitude axial fatigue test specification guide (Practiceforconductingforce controledconstantamplitudeaxialfatiguetestsofmetalicmaterials)

ASTM E467 Axial load fatigue test system Constant dynamic force calibration standard (Practiceforverificationof constantamplitudedynamicforcesinanaxial loadfatiguetestingsystem)

ASTM E468 metal material constant fatigue test results statement specification (Practiceforpresentationofconstantampli-tudefatiguetestresultsformetalicmaterials ASTM E1012 Specimen for Verification of the sample alignment test under tensile load (Preacticeforverificationofspecimenalignment undertensileloading

3 Terms and definitions

GB/T 10623 defines the terms of shear and fatigue for this document.

4 Overview of test methods