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YY/T 0988.15-2016: Coatings of surgical implants--Part 15: Test methord for abrasion resistance testing of metallic thermal spray coatings
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0988.15-2016 | English | 159 |
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Coatings of surgical implants--Part 15: Test methord for abrasion resistance testing of metallic thermal spray coatings
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YY/T 0988.15-2016
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Basic data | Standard ID | YY/T 0988.15-2016 (YY/T0988.15-2016) | | Description (Translated English) | Coatings of surgical implants--Part 15: Test methord for abrasion resistance testing of metallic thermal spray coatings | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 8,813 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 0988.15-2016: Coatings of surgical implants--Part 15: Test methord for abrasion resistance testing of metallic thermal spray coatings
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Coatings of surgical implants - Part 15. Test methord for abrasion resistance testing of metallic thermal spray coatings
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical implants - Coatings - Part 15. Heat of metals
Standard Test Method for Wear Resistance of Spray Coatings
Coatingsofsurgicalimplants-Part 15. Testmethordforabrasionresistance
testing ofmetalicthermalspraycoatings
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 terms and definitions
Test Method 1
4 meaning and application 1
5 equipment 2
6 Test sample 2
7 Step 2
8 Calculate 3
9 Report 3
Appendix A (informative) Basic principles 5
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.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This section is under the jurisdiction of the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110).
This part of the drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration
Bureau of Medical Device Technical Review Center.
The main drafters of this part. Dong Shuangpeng, Zhang Shou, Zhang Lu, Jiao Yongzhe, Liu Bin, Zhang Jiazhen, Guo Xiaolei.
Surgical implants - Coatings - Part 15. Heat of metals
Standard Test Method for Wear Resistance of Spray Coatings
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 thermalspraycoating
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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