YY/T 0988.15-2016Coatings of surgical implants - Part 15: Test method for abrasion resistance testing of metallic thermal spray coatings (English PDF)
外科植入物涂层 第15部分:金属热喷涂涂层耐磨性能试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 0988.15-2016 is the English-translated version of 外科植入物涂层 第15部分:金属热喷涂涂层耐磨性能试验方法.
YY/T 0988.15-2016 is the Chinese pharmaceutical industry standard that gives the method for quantifying the abrasion resistance of a thermally sprayed metal coating on a metal surface, as a way of characterising coatings for surgical implants.
It is the fifteenth part of the YY/T 0988 series and sets out the specimens, the abrasive and the apparatus, the number of cycles and the measurement of the material lost. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 0988.15-2016
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 terms and definitions Test Method
- 4 meaning and application
- 5 equipment
- 6 Test sample
- 7 Step
- 8 Calculate
- 9 Report
- Appendix A (informative) Basic principles
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 15 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 to refer to ASTM F1978-2007 "Taber abrasion method to test the metal thermal spray coating wear resistance" prepared by.
The technical differences between this section and ASTM F1978-2007 are as follows.
- delete chapters 2, 11 and 12 of ASTM F1978-2007;
--- change Appendix X1 to Appendix A, the same;
--- Remove the contents associated with the burner brand.
1 Scope
YY/T 0988 This part is used to quantify the wear resistance of the metal coating on the metal plane by the thermal spray method. This part of the purpose To provide a method of characterization for the coating of surgical implants.
This part of the wear instrument produced by the rolling and friction of the mixing effect of the coating surface wear. Wear through cumulative mass loss Line quantification.
This test method is only used for flat rigid specimens. The sample does not react significantly with water and does not send air between room temperature and 100 ° C Phase transformation and chemical reaction.
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 Terms and definitions
The following terms and definitions apply to this document.
2.1 Abrasive instrument
Used to test the surface withstand rolling friction compound effect of the instrument.
2.2 Particles falling off
Surface particles and debris that are peeled off from the coating.
2.3 Thermal spray coating
Through the flammable gas, plasma or arc and other methods to melt and soften the powder produced by the coating.
2.4 Quality loss
The total mass removed by the instrument during the test.
3 Test method
This part uses a wear instrument equipped with H-22 grinding wheel and 250g without weight grinding head. Repeated friction test samples, a series of weeks after the use of super Sound waves for cleaning. The sample is weighed after each cleaning, and the mass loss is the amount of wear.
4 Meaning and application
4.1 This part provides an evaluation method for the anti-particle shedding ability of thermal spray coating. Particle shedding may occur during surgical implantation It may also be caused by micro-implantation after implantation.
4.2 This method can be used for coating quality control analysis, can be used to assess the impact of process parameters, such as pre-spray preparation, surface structure,
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
YY/T 0988
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Related Standards
YY/T 0988.1-2016 — Coatings of surgical implants - Part 1: Cobalt-28 chromium-6 molybdenum powder
YY/T 0988.11-2016 — Coatings of surgical implants - Part 11: Tension testing method of calcium phosphate coating and metallic coatings
YY/T 0988.12-2016 — Coatings of surgical implants - Part 12: Shear testing method of calcium phosphate coating and metallic coatings
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