GB/T 22750.2-2024 English PDFUS$369.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 22750.2-2024: Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement Status: Valid
Basic dataStandard ID: GB/T 22750.2-2024 (GB/T22750.2-2024)Description (Translated English): Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 18,160 Date of Issue: 2024-10-26 Date of Implementation: 2025-11-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 22750.2-2024: Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT22750.2-2024 National Standard of the People's Republic of China ICS 11.040.40CCS C 35 Ceramic materials for surgical implants Part 2.Zirconia toughened high purity alumina matrix Composite materials Implants for surgery-Ceramic materials-Part 2.Composite materials based on a high purity aluminum matrix with zirconia reinforcement (ISO 6474⁃2.2019, MOD) Released on October 26, 2024 2025-11-01 Implementation State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface Ⅲ Introduction...Ⅴ 1 Scope...1 2 Normative references 1 3 Terms and Definitions 3 4 categories...3 5 Sample preparation 5 6 Test methods 6 References 11 Preface This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting is required. This document is Part 2 of GB/T 22750 “Ceramic materials for surgical implants”. GB/T 22750 has been published as follows part. --Part 1.High purity alumina ceramic materials; -- Part 2.Zirconia toughened high purity alumina matrix composites. This document is modified to adopt ISO 6474-2.2019 “Ceramic materials for surgical implants — Part 2.Zirconia-toughened high-purity alumina-based ceramics” Composite Materials". The technical differences between this document and ISO 6474-2.2019 and their reasons are as follows. --ISO 14704 was replaced by the normative reference GB/T 6569 to adapt to my country's technical conditions and increase operability (see 4.3, 6.4.3); --ISO 14705 was replaced by the normative reference GB/T 16534 to adapt to my country's technical conditions and increase operability (see 4.3, 6.7); -- The normative reference GB/T 21114 replaced ISO 12677 to adapt to my country's technical conditions and increase operability (see 4.3, 6.2); --ISO 15732 was replaced by the normative reference GB/T 23806 to adapt to my country's technical conditions and increase operability (see 4.3, 6.6.3); --ISO 18754 was replaced by the normative reference GB/T 25995 to adapt to my country's technical conditions and increase operability (see 4.3, 6.1.1, 6.1.3); --ISO 20501 was replaced by the normative reference GB/T 40005 to adapt to my country's technical conditions and increase operability (see 4.3, 6.4.4); --Replaced ASTM C1499 with the normative reference GB/T 42667 to adapt to my country's technical conditions and increase operability (See 4.3, 6.4.2); --ISO 22214 was replaced by the normative reference GB/T 43296 to adapt to my country's technical conditions and increase operability (see 4.3, 6.9); -- Replaced ISO 14242-1 with the normative reference YY/T 0651.1 to adapt to my country's technical conditions and increase operability (See 4.3, 6.10.4); --ISO 14243-1 was replaced with the normative reference YY/T 1426.1 to adapt to my country's technical conditions and increase operability (See 4.3, 6.10.4); --ISO 16428 was replaced by the normative reference YY/T 1427 to adapt to my country's technical conditions and increase operability (see 4.3, 6.9); --ISO 13356 was replaced by the normative reference YY∕T 1715 to adapt to my country's technical conditions and increase operability (see 4.3, 6.5, 6.10.4); -- Deleted the “performance classification” in Tables 1 and 2 to adapt to my country’s technical conditions and increase operability (see ISO 6474-2. 2019 (Tables 1 and 2). The following editorial changes have been made to this document. -- Changed the method for improving the contrast of grain boundary detection of zirconium oxide and aluminum oxide; (see 6.3, ISO 6474-2.2019) 6.3); -- Added backscattered electron detector and description of the linear intercept measurement method for alumina and zirconia grains (see 6.3); -- ISO 10993-1 is replaced by the informative reference GB/T 16886.1 (see Chapter 1, Chapter 1 of ISO 6474.2019); -- ISO 6474-1 is replaced by the informative reference GB/T 22750.1 (see Chapter 1, Chapter 1 of ISO 6474.2019). --Added the description of periodic inspection, and cited GB/T 2829 for informational purposes (see the note to 4.2.2). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Standardization Committee for Surgical Implants and Orthopedic Devices (SAC/TC 110). This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, National Medical Products Administration Medical Device Technical Review Center Center, Suzhou Micro-Invasive Orthopedics (Group) Co., Ltd., Shanghai Institute of Ceramics, Chinese Academy of Sciences, Dabao Medical Technology Co., Ltd., Beijing Beijing Mengtaiyin Medical Equipment Co., Ltd. The main drafters of this document are. Ma Chunbao, Zhang Qiang, Zhang Shu, Min Yue, Zhang Jiazhen, Yu Tianbai, Zheng Pengxiang, Wang Xingang, Jiang Danyu, Liang Xiongwei, Dai Jinrong, Xu Zhiyong, and Chen Wenjun.introductionThe durability of artificial joints is closely related to the tribological properties of the prosthesis. Bioceramic materials have excellent tribological properties and good Good biocompatibility is often used as friction pairs in artificial joints. GB/T 22750 “Ceramic Materials for Surgical Implants” is intended to consist of two parts. -- Part 1.High-purity alumina ceramic materials. The purpose is to standardize biostable ceramic bone substitute materials based on high-purity alumina. Material properties and corresponding test methods; -- Part 2.Zirconia toughened high purity alumina matrix composites. The purpose is to standardize the biocompatible and biostable The properties of ceramic bone substitute materials (zirconia toughened high-purity alumina-based composite materials) and corresponding test methods were determined. There is no known surgical implant material that has been proven to be completely non-toxic to the human body. Long-term clinical use of the material has shown that, if used appropriately, the expected level of biological response is acceptable. Ceramic materials for surgical implants Part 2.Zirconia toughened high purity alumina matrix Composite materials1 ScopeThis document specifies the properties of biostable ceramic bone substitute materials (zirconia toughened high purity alumina matrix composites) for joint replacement. The corresponding test methods are described. This document applies to an alumina-based composite material, i.e., alumina accounts for more than 60% by mass in the composite material, and GB/T 22750.1 describes a similar material, but with the addition of a certain amount of zirconium oxide and other composite materials with defined components. Note. The performance requirements specified in this document differ from those in GB/T 22750.1 in terms of strength and fracture toughness, and some requirements for materials containing zirconium oxide are added. Special requirements for (see YY∕T 1715). The chemical composition specified in this document lists the additives. Typical additives for alumina or zirconia ceramics are Mg, Y, Ce, etc. These additives help improve the mechanical properties and chemical stability of alumina-zirconia composites. This document does not include the evaluation of biocompatibility (see GB/T 16886.1). The biocompatibility of ceramic materials is the responsibility of the manufacturer. 2 Normative references The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 6569 Test method for flexural strength of fine ceramics (GB/T 6569-2006, ISO 14704.2000, MOD) GB/T 16534 Test method for room temperature hardness of fine ceramics (GB/T 16534-2009, ISO 14705.2008, MOD) GB/T 21114 Refractory materials - X-ray fluorescence spectrochemical analysis - Cast glass disc method (GB/T 21114-2019, ISO 12677.2011, MOD) GB/T 23806 Test method for fracture toughness of fine ceramics - Single edge precracked beam (SEPB) method (GB/T 23806-2009, ISO 15732.2003, MOD) GB/T 25995 Test method for density and apparent porosity of fine ceramics (GB/T 25995-2010, ISO 18754.2003, MOD) GB/T 40005 Weibull statistical analysis method for strength data of fine ceramics (GB/T 40005-2021, ISO 20501.2019, MOD) GB/T 42667 Fine ceramics room temperature equibiaxial bending strength test method double ring method (GB/T 42667-2023, ISO 17167.2018, MOD) GB/T 43296 Test method for room temperature bending fatigue properties of fine ceramics (GB/T 43296-2023, ISO 22214.2006, MOD) YY/T 0651.1 Implants for surgery - Wear of total hip prostheses - Part 1.Load and displacement parameters of wear testing machines and Relevant test environment conditions YY/T 1426.1 Implants for surgery - Wear of total knee prostheses - Part 1.Load and wear test of load-controlled wear testing machines Displacement parameters and related test environment conditions YY/T 1427 Test solutions and conditions for static and dynamic corrosion testing of surgical implants, implantable materials and medical devices ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 22750.2-2024_English be delivered?Answer: Upon your order, we will start to translate GB/T 22750.2-2024_English as soon as possible, and keep you informed of the progress. 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