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YY/T 0988.13-2016: Coatings of surgical implants--Part 13: Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating
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| YY/T 0988.13-2016 | English | 239 |
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Coatings of surgical implants--Part 13: Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating
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YY/T 0988.13-2016
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Basic data | Standard ID | YY/T 0988.13-2016 (YY/T0988.13-2016) | | Description (Translated English) | Coatings of surgical implants--Part 13: Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 12,151 | | 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 0988.13-2016: Coatings of surgical implants--Part 13: Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating
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Coatings of surgical implants - Part 13. Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical implants - Coatings - Part 13. Calcium phosphate,
Metal and calcium phosphate/metal composite coating shear
And bending fatigue test methods
Coatingsofsurgicalimplants-Part 13. Testmethodforshearandbending
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 Overview of test methods 1
5 meaning and application 2
Equipment and equipment
7 Bond material 4
8 Test sample 5
9 Step 6
10 trial termination 7
Stress calculation
12 Report 7
Appendix A (informative) Principle 9
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.
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. Zhang Shu, Dong Shuangpeng, Zhang Lu, Jiao Yongzhe, Liu Yinghui, Dong Wensing, Zhang Jiazhen.
Surgical implants - Coatings - Part 13. Calcium phosphate,
Metal and calcium phosphate/metal composite coating shear
And bending fatigue test methods
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 article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
Test terminology for mechanical properties of metallic materials GB/T
ASTME206 Fatigue test and fatigue data Statistical analysis Definition of related terms (Definitionsoftermsrelatingto
fatiguetestingandthestatisticalanlysisoffatiguedata)
ASTME466 metal material force control constant amplitude axial fatigue test specification guide (Practiceforconductingforce
controledconstantamplitudeaxialfatiguetestsofmetalicmaterials)
ASTME467 Axial load fatigue test system Constant dynamic force calibration standard (Practiceforverificationof
constantamplitudedynamicforcesinanaxial loadfatiguetestingsystem)
ASTME468 metal material constant fatigue test results statement specification (Practiceforpresentationofconstantampli-
tudefatiguetestresultsformetalicmaterials
ASTME1012 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
4.1 shear fatigue test
4.1.1 The purpose of the shear fatigue test is to determine the bond and/or bond strength of the coating.
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