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YY/T 0988.12-2016Coatings of surgical implants - Part 12: Shear testing method of calcium phosphate coating and metallic coatings (English PDF)

外科植入物涂层 第12部分:磷酸钙涂层和金属涂层剪切试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 23, 2016

Implementation date

January 1, 2017

Scope

YY/T 0988.12-2016 is the English-translated version of 外科植入物涂层 第12部分:磷酸钙涂层和金属涂层剪切试验方法.

YY/T 0988.12-2016 is the Chinese pharmaceutical industry standard that gives the shear test for the adhesion of a continuous calcium phosphate coating or a metal coating to a dense metal substrate at room temperature, the load being applied parallel to the interface.

It is the twelfth part of the YY/T 0988 series and sets out the specimens, the fixture, the loading and the calculation of the shear strength. Issued on 23 March 2016, it has applied since 1 January 2017.

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Document preview — YY/T 0988.12-2016

National Standard of the People's Republic of China

ICS
11.040.40
Classification
C 35

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Preface
  • 1 Scope
  • 2 normative reference document
  • 3 Terms and definitions
  • 4 Overview of test methods
  • 5 meaning and application
  • 7 Bond material
  • 8 Test sample
  • 9 Step
  • 10 Stress calculation
  • 11 Report
  • Appendix A (informative) Principle

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 part is part 12 of YY/T 0988.

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

This part uses the re-drafting method in accordance with ASTM F1044-2005 "Calcium phosphate coating and metal coating shear test method" preparation.

The technical differences between this part and ASTM F1044-2005 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 GBME8 with GB/T 228.1 - replace GBME6 with GB/T 10623; Replace GBME4 with GB/T 16825.1.

1 Scope

This part of YY/T 0988 specifies a continuous calcium phosphate coating and a metal coating bonded to a dense metal substrate at room temperature Of the shear test method. This part is used to evaluate the degree of adhesion of the coating to the substrate in the shear form (parallel to the direction of the bond plane) Department of the degree of integration. 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 the user of this section to establish appropriate safety and health practices and to apply the limits of management clearly 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.

Metallic materials - Tensile testing - Part 1. Test methods for room temperature GB/T Test terminology for mechanical properties of metallic materials GB/T

GB/T 16825.1 Tests for static uniaxial testing machines - Part 1. Tests for force measurement systems of tension and/or pressure testing machines calibration

3 Terms and definitions GB/T 10623

The terms and definitions defined apply to this document.

4 Overview of test methods

4.1 Shear method of calcium phosphate or metal coating

4.1.1 This test method applies a shear load to a sample consisting of a coated part and an uncoated part. Samples can pass Thermal bonding (e.g., sintering or diffusion bonding), or bonding using a polymeric binder. The binder may be a film or a block, But its shear strength should be no less than 34.5MPa, or the coating required the minimum bond strength or minimum shear strength as large Prevail.

4.1.2 When testing with a tensile tester, the shear load shall be parallel to the coating plane to determine the maximum bonding strength of the coating or The bond strength of the layer on the substrate surface.

4.2 Cut method for metal coating only

A shear load is applied to the porous coating in the lap shear process, usually using a suitable polymeric binder or bone cement binder The test machine tests the fixture to determine the maximum shear strength required for the separation of the assembly (ie, the shear bond strength of the coating/matrix bond or the shear Cut joint strength).

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

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