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GB/T 23101.4-2023 English PDF

GB/T 23101.4-2023 (GB/T23101.4-2023, GBT 23101.4-2023, GBT23101.4-2023)
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GB/T 23101.4-2023English229 Add to Cart 3 days [Need to translate] Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength Valid GB/T 23101.4-2023
GB 23101.4-2008English85 Add to Cart 0--9 seconds. Auto-delivery [GB/T 23101.4-2008] Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength Valid GB 23101.4-2008
Standards related to: GB/T 23101.4-2023

BASIC DATA
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Older Standard (superseded by this standard) GB/T 23101.4-2008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


GB/T 23101:4-2023: Hydroxyapatite for surgical implants Part 4: Determination of coating bond strength ICS 11:040:40 CCSC35 National Standards of People's Republic of China Replace GB/T 23101:4-2008 Surgical Implants Hydroxyapatite Part 4: Determination of bond strength of coatings Implantsforsurgery-Hydroxyapatite- (ISO 13779-4:2018,MOD) Published on 2023-11-27 Implemented on 2024-12-01 State Administration for Market Regulation Released by the National Standardization Administration Committee Table of contents PrefaceⅠ Introduction III 1 range 1 2 Normative references 1 3 Terms and Definitions 1 4 Determination of bond strength of hydroxyapatite coating 1 5 Test report of tensile test of hydroxyapatite coating 4 Reference 5 Preface This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting: This document is Part 4 of GB/T 23101 "Hydroxyapatite for Surgical Implants": GB/T 23101 has released the following part: ---Part 1: Hydroxyapatite ceramics; ---Part 2: Hydroxyapatite coating; ---Part 3: Chemical analysis and characterization of crystallinity and phase purity; ---Part 4: Determination of coating bond strength; ---Part 6: Powder: This document replaces GB/T 23101:4-2008 "Surgical Implants Hydroxyapatite Part 4: Measurement of Coating Bonding Strength" "Standard", compared with GB/T 23101:4-2008, in addition to structural adjustments and editorial changes, the main technical changes are as follows: ---The scope of application has been changed to clarify that this document applies to adhesives expected to be used for hydroxyapatite coatings on metal base components of surgical implants: Knot strength test method (see Chapter 1, Chapter 1 of the:2008 edition); ---Changed terms and definitions (see Chapter 3, Chapter 3 of the:2008 edition); ---Deleted the size requirements for loading components (see 4:2:2 of the:2008 version); ---Changed the dimensional requirements for test components (see 4:2:3,:2008 version of 4:2:3); ---Changed the requirements for binders (see 4:2:4,:2008 version of 4:2:4); --- Added requirements for the number of test samples (see 4:3:1); ---Added an evaluation method for the thickness of the coating being measured (see 4:3:2); ---Deleted the requirements for the use of polymer binders and alignment of test components (see 4:4 of the:2008 edition); ---Changed the loading rate of the tensile test (see 4:3:3, 4:5 of the:2008 edition); ---Changed the determination principle of effective testing (see 4:3:3, 4:5 of the:2008 version): This document has been modified to adopt ISO 13779-4:2018 "Hydroxyapatite for Surgical Implants Part 4: Determination of Coating Bond Strength": The technical differences between this document and ISO 13779-4:2018 and their reasons are as follows: ---Added relevant instructions on the principles of effective test judgment (see 4:3:3) to facilitate standard users to choose the ones that are suitable for their own test situations: Judgment principles and improve the operability of standards; --- Added relevant instructions for reporting coating bond strength in the test report (see Chapter 5) to clarify the bond strength under different test situations: degree reporting requirements; ---Replaced ISO 5832-1 with normatively cited GB 4234:1 to adapt to my country's national conditions; ---Replaced ISO 7500-1 with normatively quoted GB/T 16825:1 to adapt to my country's national conditions; ---Replaced ISO 13779-3 with normatively cited GB/T 23101:3 to adapt to my country's national conditions: Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents: This document is proposed by the National Medical Products Administration: This document is under the jurisdiction of the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110): This document was drafted by: Stryker (Beijing) Medical Devices Co:, Ltd:, Tianjin Medical Device Quality Supervision and Inspection Center, National Pharmaceutical Medical Device Technical Review Center of the National Medical Products Administration, Greater Bay Area Center for Medical Device Technical Review and Inspection of the National Medical Products Administration, Sichuan University School, 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, Evaluation and Certification Co:, Ltd:, Suzhou Ding'an Technology Co:, Ltd:, Smith & Nephew Medical Products International Trading (Shanghai) Co:, Ltd: The main drafters of this document: Zhang Haiming, Zhang Songwei, Zhao Binghui, Wang Zhijie, Shi Xinli, Min Yue, Han Dan, Ding Jinju, Gao Jintao, Li Zheng, Deng Xiang, Yuan Dun, Liu Zhenzhen, Yu Tianbai, Li Xuan, Zeng Da, Peng Haiyun, Dong Xiang, Li Mei, Zhai Yanan, Li Chenglin, Li Yadong, Li Yajun, Li Chenxi, Hao Ruixing: The previous versions of this document and the documents it replaces are as follows: ---First published as GB/T 23101:4-2008 in:2008; ---This is the first revision: introduction Hydroxyapatite, as a bone repair material, is widely used in surgical implants: GB/T 23101 "Hydroxyapatite for Surgical Implants" was transformed from the ISO 13779 series of standards and provides hydroxyapatite ceramics Performance requirements and related test methods for porcelain, hydroxyapatite coatings and hydroxyapatite powders: GB/T 23101 has been published in 5 parts, including: ---Part 1: Hydroxyapatite Ceramics, intended to standardize the requirements for hydroxyapatite ceramics used as surgical implants; ---Part 2: Hydroxyapatite coatings, intended to standardize hydroxyapatite ceramic coatings applied to metallic and non-metallic surgical implants requirements; ---Part 3: Chemical analysis and characterization of crystallinity and phase purity, intended to provide hydroxyapatite materials, including powders, coatings or ceramics Determination methods for chemical analysis, crystallinity and phase composition evaluation of porcelain; ---Part 4: Determination of bond strength of coatings, intended to provide a method for measuring the bond strength of hydroxyapatite coatings; ---Part 6: Powder, intended to standardize the requirements for raw materials of hydroxyapatite powder: This document details a preliminary method for measuring the bonding properties of coatings under dry conditions, with the aim of ensuring optimal coating performance during implantation: Low mechanical properties: The hydroxyapatite coating is designed to promote bonding and bonding with bone: Therefore, during the osseointegration process of the coating after implantation, the coating The mechanical strains in and the mechanical properties of the coating will change with time: The minimum performance requirements defined in ISO 13779-2 are for coatings to Maintain its shape (thickness, roughness, etc:) during implantation and avoid chipping and peeling of the coating during implantation: Surgical Implants Hydroxyapatite Part 4: Determination of bond strength of coatings 1 Scope This document describes a bond strength test method for hydroxyapatite coatings intended for use on metal-based components of surgical implants: Note: For requirements on testing laboratory capabilities, see GB/T 27025-2019: This document applies to a test method for the bond strength of hydroxyapatite coatings intended for use on metal-based components of surgical implants: 2 Normative reference documents The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document: GB 4234:1 Metallic materials for surgical implants Part 1: Forged stainless steel (GB 4234:1-2017, ISO 5832-1: 2007,MOD) GB/T 16825:1 Inspection and calibration of static uniaxial testing machines for metallic materials Part 1: Tensile and/or pressure tests Inspection and calibration of machine force measuring systems (GB/T 16825:1-2022, ISO 7500-1:2018, IDT) GB/T 23101:3 Hydroxyapatite for surgical implants Part 3: Chemical analysis and characterization of crystallinity and phase purity (GB/T 23101:3-2023,ISO 13779-3:2018,MOD) ISO 5832-3 Metallic materials for surgical implants Part 3: Forged titanium-6 aluminum-4 vanadium alloy (Implants for surgery- 3 Terms and definitions The following terms and definitions as defined in GB/T 23101:3 apply to this document: 3:1 Adhesionstrength The tensile strength at the interface between the coating and the substrate or within the coating: Note: For the purpose of this document, bond strength and cohesive strength are expressed in terms of bond strength: 4 Determination of bond strength of hydroxyapatite coating 4:1 Principle Coating bond strength is measured by applying a uniaxial tensile load to a cylindrical test assembly consisting of a hydroxyl The sample consists of an apatite-based coating bonded to an uncoated component: 4:2 Test equipment 4:2:1 Mechanical testing machine The load capacity is not less than 30kN, and the accuracy is ±2% of the full-scale reading: The applied tensile load should be perpendicular to the plane of the coating:
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 ......