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GB/T 23101.4-2023: Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
Status: Valid GB/T 23101.4: Evolution and historical versions
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| GB/T 23101.4-2023 | English | 229 |
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Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
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GB/T 23101.4-2023
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| GB 23101.4-2008 | English | 85 |
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[GB/T 23101.4-2008] Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strength
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PDF similar 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Count Estimation | 11,139 | | Date of Issue | 2023-11-27 | | Date of Implementation | 2024-12-01 | | Older Standard (superseded by this standard) | GB/T 23101.4-2008 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 23101.4-2023: Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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 Scope 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
Foreword
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:
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