GB/T 23101.4-2023 (GB/T23101.4-2023, GBT 23101.4-2023, GBT23101.4-2023) & related versions
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Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength
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[GB/T 23101.4-2008] Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength
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GB/T 23101.4-2023: PDF in English (GBT 23101.4-2023)
GB 23101.4-2008
Implants for surgery.Hydroxyapatite.Part 4. Determination of coating adhesion strength
ICS 11.040.40
C35
National Standards of People's Republic of China
GB 23101.4-2008/ISO 13779-4.2002
Surgical implants of hydroxyapatite
Determination of coating adhesion strength. Part 4
(ISO 13779-4.2002, IDT)
Posted 2008-12-30
2010-03-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
All technical content in this section is mandatory.
GB 23101 "surgical implants hydroxyapatite" is divided into four parts.
--- Part 1. Ceramic hydroxyapatite;
--- Part 2. hydroxyapatite coating;
--- Part 3. degree of crystallinity and phase purity of the chemical analysis and characterization;
--- Part 4. Determination of coating adhesion strength.
This is Part 4 GB 23101's.
This part identical with ISO 13779-4.2002 "Implants for surgery - Hydroxyapatite - Part 4. Determination of coating adhesion strength."
This part is proposed by the State Food and Drug Administration.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized.
This section is drafted. the Center for Biological Materials Engineering, Sichuan University, National Biomedical Engineering Research Center.
The main drafters of this section. Cao Yang, Chen Ji Yong, Zhang Xingdong.
GB 23101.4-2008/ISO 13779-4.2002
introduction
Currently known surgical implant material has not been demonstrated to completely non-toxic side effects on the human body. But the material covered in this section
In long-term clinical applications show that if applied appropriately, the expected level of biological response is acceptable.
The biological response of hydroxyapatite ceramic have been long-term clinical applications and Laboratory confirmed. See References.
GB 23101.4-2008/ISO 13779-4.2002
Surgical implants of hydroxyapatite
Determination of coating adhesion strength. Part 4
1 Scope
GB 23101 of the measurement methods specified in this part of hydroxyapatite coating adhesion strength.
2 Normative references
The following documents contain provisions which, through reference in this Part of GB 23101, constitute provisions of this part. For dated reference documents
Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section
Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this
section.
Check tension and (or) pressure testing machine force measuring system. GB/T 16825.1-2002 static uniaxial testing machines - Part 1
Test and calibration (ISO 7500-1.1999, IDT)
3 Terms and Definitions
The following terms and definitions apply to this part of GB 23101.
3.1
By sintering the powder grains integrated into cohesion hydroxyapatite crystals block.
3.2
By heat, vapor or liquid phase technique in a non-metal or metal deposited on the surface of distinct layers of different materials.
3.3
Having a crystal structure of the International Commission for Diffraction Data (ICDD) powder diffraction card PDF9-432 characterized by chemical composition.
Note. Chemical formula. Ca5 (OH) (PO4) 3.
3.4
By heating the powder particle surface area and a significant reduction in the overall volume of the powder and densified, and followed by improving the mechanical properties of ceramics
production process.
4 Determination of coating adhesion strength
4.1 Principle
Coating adhesion strength is measured on a cylindrical test assembly by applying a uniaxial tensile load, the test assembly consists of a hydroxyl
Hydroxyapatite coating sample uncoated bond a member.
4.2 Test Equipment
4.2.1 mechanical testing machine
Load capacity of not less than 30kN, accuracy no less than ± 2% of full scale mechanical testing machine. The tensile load shall be applied perpendicular to the applied coating
on flat surface.
GB 23101.4-2008/ISO 13779-4.2002
(According to GB/T 16825.1 test and calibration of mechanical measuring system)
4.2.2 Load component
The load test machine is transmitted to the apparatus test assembly.
Load component should ensure that the shaft and the shaft of the test assembly test deviation between ≤1 ° and ± 0.1mm, thus ensuring vertical surface coating test
To the loading axis. Eccentric loading resulting assembly results invalid.
Figure 1 is a combination of one of the yoke and pin from the loading component instance to meet these requirements. The samples were coated and uncoated parts
Each consists of two vertical pins fixed to allow for axial load deviation is minimized. The specific dimensions charging assembly as specified in Table 1, the appropriate
Close to the expected maximum bond or cohesive strength of the coating test samples 50MPa.
1 --- test module;
2 --- pin;
3 --- yoke;
4 --- binder;
5 --- coating to be tested.
Figure 1 so that the smallest deviation from axial loading loading component diagram
4.2.3 Test assembly
Test component parts (the coated samples and uncoated parts) are bonded together with a polymeric binder.
Uncoated substrate samples with the coating member should be the same material, preferred materials are shown in Table 1.
Size uncoated parts shall be coated sample size and the same dimensions and tolerances are shown in Table 1.
Loading and testing of components shown in Figure 2, the provisions applicable to the expected size of the component adhesive or cohesive strength of up to 50MPa coating
test.
Note 1. The accuracy of this test method is very sensitive to the following factors. Preparation of coated sample, the polymer binder and the use of coated samples and uncoated
Appropriate member of the school straight. Poor alignment can lead to eccentric loads and bending stress on the test assembly, the test result is invalid.
Note 2. The bonding surface uncoated parts shall be roughened to aid polymer adhesive bond.
GB 23101.4-2008/ISO 13779-4.2002
1 --- for hydroxyapatite coating deposited on the surface.
Symbols and dimensions defined in Table 1.
4.2.4 polymeric binder
Bond strength greater than 30MPa at least a polymeric binder, or at least higher than the coating adhesion or cohesive strength 5MPa, whichever is larger
value. Polymer binder used in all the test report shall be marked.
If the coating is porous portion extended to the coating/substrate interface should operate through careful selection of the coating and to ensure sufficient tack adhesive poly
Polymer binder will not penetrate through the coating to the substrate. Binder penetrate the substrate through the coating will cause the measured result is invalid.
Penetration of the binder can be assessed by examining the cross-section of the test piece.
4.3 coating sample preparation
Carefully prepared coating sample. Before assembly and test first checks all samples removed during the test found no special representative
Special coating sample. Hydroxyapatite coating on the coated samples not to be machined. Coating area to be tested shall be the nominal straight
Circular diameter of 25mm (tolerance Table 1) or an equivalent cross-sectional area. Measure and record the cross-sectional area and the sample size coating.
GB 23101.4-2008/ISO 13779-4.2002
If using a sample size or other cross-sectional area, and the resulting data should demonstrate a nominal diameter of 25mm circular sample data is relative
And the like.
4.4 School polymeric binder used and tested components straight
Polymer binder should be applied to the coating once the shaft center. It should control the amount of adhesive and the two parts are pressed together in order to maintain the force
Card in coated samples/uncoated part is not formed at the flange connection. Excess adhesive after curing, the application does not harm the integrity of the test assembly
A method for removing. The thickness of the adhesive on the contact surface and parallel test sectional uncoated parts with a binder/coating sample is contacted, and to ensure that
Uniform.
To ensure uniaxial testing component alignment during the curing polymeric binder, a required test straightening means rigidly fixed component. This
A device should be able to provide a constant load (typically 0.2MPa) to compensate for shrinkage of the adhesive during curing component.
Table 1 for bonding or adhesive strength of the coating is less than the 50MP Rao test fixture and sample size
Symbol test components/fixtures
Dimensions/mm
Titanium alloy (Ti6Al4V) 316 stainless steel
Ladder-type test piece 25 ± 0.05 25 ± 0.05
Straight test piece 25-0.02-0.041 25-0.02-0.041
Rao sample segment shank diameter 20-0.02-0.041 18-0.02-0.041
Chou pin hole diameter 9 + 8 + 0 0.015 0 0.015
Ba sample hole depth 14 ± 0.1 12 ± 0.1
Ladder-type test member 20 + 18 + 0 0.033 0 0.033
Straight test piece + 25 + 25 0.033 0.033 0 0
Ladder-type test piece 40 ± 0.1 35 ± 0.1
Straight test piece 45 ± 0.1 45 ± 0.1
K yoke inside of the depth of 40 ± 0.1 40 ± 0.1
4.5 Test procedure
The test assembly is placed in a tensile tester jig to match the direction of pull exerted by the longitudinal direction. Tensile load to
(1.0 ± 0.01) mm/min constant speed is applied until the entire test assembly is fully extended. Record the maximum load is applied, accurate to 100N.
Use 10 × optical magnification examination to confirm the failure occurred within the coating rather than coating - adhesive contact surface.
4.6 Calculation of coating adhesion strength
Coating adhesion or cohesive strength σ, in units of megapascals (MPa), with the following formula.
σ = FA
Where.
--- F. The maximum load, in units of bovine (the N);
A --- cross-sectional area (usually 490.87mm2), to calculate accurate ± 0.5mm2.
GB 23101.4-2008/ISO 13779-4.2002
5 hydroxyapatite coating tensile test report
The test report shall include the following.
a) based on national standards of this section;
b) indicate the test component materials, including polymeric binder component type and uncoated materials. Report for bonding uncoated table
Various surface roughness and surface treatment details of the test surface;
c) the number of test samples;
d) detailing the method used in the production of coated samples and coated samples with a variety of information related to connection, such as the date, lot number;
e) Each coated samples and uncoated components All dimensions, and cross-sectional area and thickness of the adhesive coating of hydroxyapatite;
f) All of the maximum load and fracture mode (for example, or between the coating and the substrate within the coating fracture);
g) the bond strength of the following values. maximum, minimum, average and standard deviation;
h) the extent of penetration of the binder into the substrate;
i) identify the fault is in the coating side of the substrate, rather than adhesive - substrate interface.
GB 23101.4-2008/ISO 13779-4.2002
references
[1] ISO 13779-1, Implantsforsurgery-Hydroxyapatite-Part 1. Ceramichydroxyapatite
[2] ISO 13779-2, Implantsforsurgery-Hydroxyapatite-Part 2. Coatingsofhydroxyapatite
[3] ASTMF1609.1995, Standardspecificationforcalciumphosphatecoatingsforimplantable
materials
[4] ASTMF1185. 1988, Standardspecificationforcompositionofceramichydroxyapatitefor
surgicalimplants
[5] ASTM C633-79. 1979, Standardtestmethodforadhesionorcohesionstrengthofflame
sprayedcoatings
[6] BS5350-C15.1990, Methodsoftestforadhesives. Adhesivelybondedjoints. mechanical
tests. Determinationofbondstrengthincompressiveshear
[7] JISH8666.1994, Testmethodsforceramicsprayedcoatings
[8] NFS94-072, Materialsforsurgicalimplants-Determinationoftensileadherenceofphosph-
ocalciccoatingsforbiomedicalapplications
GB 23101.4-2008/ISO 13779-4.2002
......
| Standard ID | GB/T 23101.4-2023 (GB/T23101.4-2023) | | Description (Translated English) | Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 11,146 | | Date of Issue | 2023-11-27 | | Date of Implementation | 2024-12-01 | | Older Standard (superseded by this standard) | GB/T 23101.4-2008 | | Drafting Organization | Stryker (Beijing) Medical Devices Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, Medical Device Technical Review Center of the State Food and Drug Administration, Greater Bay Area Center for Medical Device Technical Review and Inspection of the State Food and Drug Administration, Sichuan University , Guangdong Medical Device Quality Supervision and Inspection Institute, Suzhou Minimally Invasive Joint Medical Technology Co., Ltd., Dabo Medical Technology Co., Ltd., Beijing Natong Medical Technology Holdings Co., Ltd., Guohe General Testing and Evaluation Certification Co., Ltd., Suzhou Ding'an Technology Co., Ltd. Company, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. | | Administrative Organization | National Technical Committee on Standardization of Surgical Implants and Orthopedic Instruments (SAC/TC 110) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration |
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