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YY/T 0988.11-2016: Coatings of surgical implants--Part 11: Tension testing method of calcium phosphate coating and metallic coatings
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| YY/T 0988.11-2016 | English | 219 |
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Coatings of surgical implants--Part 11: Tension testing method of calcium phosphate coating and metallic coatings
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YY/T 0988.11-2016
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Basic data | Standard ID | YY/T 0988.11-2016 (YY/T0988.11-2016) | | Description (Translated English) | Coatings of surgical implants--Part 11: Tension testing method of calcium phosphate coating and metallic coatings | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 11,179 | | 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 0988.11-2016: Coatings of surgical implants--Part 11: Tension testing method of calcium phosphate coating and metallic coatings
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Coatings of surgical implants - Part 11. Tension testing method of calcium phosphate coating and metallic coatings
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical implants - Coatings - Part 11. Calcium phosphate
Coating and Metallic Coating Tensile Test Methods
Coatingsofsurgicalimplants-Part 11. Tensiontestingmethodofcalcium
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 Sample Method Overview 1
5 meaning and application 1
Equipment and equipment
Material 3
8 Test sample 4
9 Test Step 4
10 Calculate 5
11 Report 5
Appendix A (Normative Appendix) Procedure for Adhesing Porous Coating Specimens Using SCOTCH-WELD2214-NMF Structural Adhesives 6
Appendix B (Normative Appendix) Procedure for Adhesion of Porous Coating Specimens Using FM1000 Film Adhesives 7
Appendix C (informative) Principle 8
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 11 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 F1147-2011 "Calcium phosphate and metal coating tensile test method" preparation.
The technical differences between this section and ASTM F1147-2011 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.
- adjust the units in the standard to the international unit system.
- Remove Chapter 12, Chapter 13 and Appendix X2 of ASTM F1147-2011.
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, a medical equipment (China)
Limited company.
The main drafters of this section. Zhang Lu, Zhang Shu, Dong Shuangpeng, Jiao Yongzhe, Chen Changsheng.
Surgical implants - Coatings - Part 11. Calcium phosphate
Coating and Metallic Coating Tensile Test Methods
1 Scope
This part of YY/T 0988 specifies a calcium phosphate coating and a metal porous coating that covers the dense metal substrate at room temperature
Of the tensile test method. This part is used to evaluate the degree of adhesion of the coating to the substrate in the stretched form (perpendicular to the direction of the bond plane)
Layer 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. establish
Appropriate safety and health practices, as well as the applicability of regulatory restrictions before application, are the responsibility of the user's own part.
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.
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. Validation and calibration of force measuring systems for tension and/or pressure testing machines
3 terms and definitions
GB/T 10623 The terms and definitions defined apply to this document.
4 Sample Method Overview
4.1 This test method applies a tensile load to a sample consisting of a coated part and an uncoated part. If coated with calcium phosphate
Layer, the test parts should be bonded together with a polymeric binder. If the metal coating, parts can be bonded together, can also be sintered together.
The binder may be in the form of a film or a block, but its tensile strength shall be not less than 34.5 MPa, or the minimum bond strength or minimum required for the coating
Tensile strength as large, whichever is greater.
4.2 When testing with a tensile tester, the tensile load shall be perpendicular to the plane of the coating to determine the maximum bond strength or coating of the coating
The bond strength on the surface of the substrate.
5 meaning and application
5.1 This section recommends a tensile test method for the combination of calcium phosphate/matrix or porous metal coating/matrix to provide a coating
Axis) under tensile stress or bond strength (see Appendix C).
5.2 This part can be used to evaluate the bonding or bonding strength of different types of coatings. Coatings can use a variety of different parties
Production, including but not limited to plasma spraying and sintering. The information obtained by this test method can be used for quality control and design.
5.3 This part does not apply to the provision of parameters directly involved in the calculation, such as the ability to determine the resistance of the coating against specific environmental stresses.
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