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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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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0988.12-2016 | English | 239 |
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Coatings of surgical implants--Part 12: Shear testing method of calcium phosphate coating and metallic coatings
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YY/T 0988.12-2016
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Basic data | Standard ID | YY/T 0988.12-2016 (YY/T0988.12-2016) | | Description (Translated English) | Coatings of surgical implants--Part 12: Shear 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 | 12,174 | | 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 0988.12-2016: Coatings of surgical implants--Part 12: Shear testing method of calcium phosphate coating and metallic coatings
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Coatings of surgical implants - Part 12. Shear 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 12. Calcium phosphate
Coating and metal coating shear test methods
Coatingsofsurgicalimplants-Part 12. Sheartestingmethodof
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 5
8 Test sample 5
9 Step 6
10 Stress calculation
11 Report 8
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 part is part 12 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 F1044-2005 "Calcium phosphate coating and metal coating shear test method" preparation.
The technical differences between this part and ASTM F1044-2005 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 GBME8 with GB/T 228.1
● replace GBME6 with GB/T 10623;
Replace GBME4 with GB/T 16825.1.
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. Tianjin Medical Device Quality Supervision and Inspection Center, Chuangsheng Medical Devices (China) Co., Ltd.
This part of the main drafters. Zhang, Li Nan, Dong Shuangpeng, Zhang Lu, Jiao Yongzhe, Chen Changsheng.
Surgical implants - Coatings - Part 12. Calcium phosphate
Coating and metal coating shear test methods
1 Scope
This part of YY/T 0988 specifies a continuous calcium phosphate coating and a metal coating bonded to a dense metal substrate at room temperature
Of the shear test method. This part is used to evaluate the degree of adhesion of the coating to the substrate in the shear form (parallel to the direction of the bond plane)
Department 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. Indeed
It is the responsibility of the user of this section to establish appropriate safety and health practices and to apply the limits of management clearly 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.
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. Tests for force measurement systems of tension and/or pressure testing machines
calibration
3 terms and definitions
GB/T 10623 The terms and definitions defined apply to this document.
4 Overview of test methods
4.1 Shear method of calcium phosphate or metal coating
4.1.1 This test method applies a shear load to a sample consisting of a coated part and an uncoated part. Samples can pass
Thermal bonding (e.g., sintering or diffusion bonding), or bonding using a polymeric binder. The binder may be a film or a block
, But its shear strength should be no less than 34.5MPa, or the coating required the minimum bond strength or minimum shear strength as large
Prevail.
4.1.2 When testing with a tensile tester, the shear load shall be parallel to the coating plane to determine the maximum bonding strength of the coating or
The bond strength of the layer on the substrate surface.
4.2 Cut method for metal coating only
A shear load is applied to the porous coating in the lap shear process, usually using a suitable polymeric binder or bone cement binder
The test machine tests the fixture to determine the maximum shear strength required for the separation of the assembly (ie, the shear bond strength of the coating/matrix bond or the shear
Cut joint strength).
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