YY/T 0988.1-2016Coatings of surgical implants - Part 1: Cobalt-28 chromium-6 molybdenum powder (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 part is part 1 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 for reference ASTM F1377-2008 "Standard Specification for Coated-Co-2 + Chromium-6 Molybdenum Powder for Orthopedic Implant Coatings Fan "system.

The technical differences between this section and ASTM F1377-2008 are as follows.

--- on the normative reference documents, this part made a technical differences in the adjustment, delete the ASTM F1377-2008 in the 2.2 And 2.3 to meet the technical conditions of our country.

- Remove Chapter 3, Chapter 9, Chapter 10, Chapter 11 of ASTM F1377-2008.

1 Scope

YY/T 0988 This section specifies the cobalt-28 chromium-6 molybdenum alloy powder for the formation of a coating on a cobalt-28 chromium-6 molybdenum implant Claim.

The powder specified in this section may be formed by a sintering process or a thermal spraying process.

This section specifies the requirements of the powder and does not apply to the performance of the powder made of the coating.

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. ASTMB214 metal powder sieving standard test method (Testmethodforsieveanalysisofmetalpowders) Standard Practice for the Sampling of ASTMB215 Metal Powders (Practicesforsamplingmetalpowders) ASTM E11 Specification for Wire Mesh Screening (Specificationforwireclothandsievesfortestingpurposes)

Standard Test Method for Chemical Analysis of ASTM E354 High Temperature Steel, Electrical Steel, Magnet and Other Similar Iron, Nickel and Cobalt Alloys (Test methodsforchemicalanalysisofhigh-temperature, electrical, magnetic, andothersimilariron, nickel, andcobaltaloys)

3 Meaning and application

The coating made of metal powder has been widely used in improving the adhesion of tissue and non-cement fixed joint prosthesis. Such coating also Can improve the adhesion of acrylic resin bone cement and prosthesis. This section specifies the specific requirements for the coating of metallic powders. Principle and health See Annex A and Appendix B for compatibility.

4 Manufacturing method

The powder may be subjected to a plasma rotary electrode method, an inert gas atomization method or other method capable of producing a powder satisfying the requirements of this part.

5 Chemical requirements

5.1 The raw material thermal analysis results of the powder shall be in accordance with Table 1.