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GB/T 22750.1-2024 English PDF

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US$329.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 22750.1-2024: Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
Status: Valid

GB/T 22750.1: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 22750.1-2024	329	Add to Cart	4 days	Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina	Valid
GB/T 22750-2008	194	Add to Cart	3 days	Implants for surgery -- Ceramic materials based on high purity alumina	Valid

Similar standards

GB/T 24627 GB/T 19701.2 GB 23101.2 GB/T 12417.2 GB 16174.2 GB/T 22750.2

Basic data

Standard ID: GB/T 22750.1-2024 (GB/T22750.1-2024)
Description (Translated English): Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 16,157
Date of Issue: 2024-10-26
Date of Implementation: 2025-11-01
Older Standard (superseded by this standard): GB/T 22750-2008
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 22750.1-2024: Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina

---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/GBT22750.1-2024
National Standard of the People's Republic of China ICS 11.040.40CCS C 35 Ceramic materials for surgical implants Part 1.High-purity alumina ceramic materials Implants for surgery-Ceramic materials- Part 1.Ceramic materials based on high purity alumina (ISO 6474⁃1.2019, MOD) Released on October 26, 2024 2025-11-01 Implementation State Administration for Market Regulation The National Standardization Administration issued Replaces GB/T 22750-2008

Preface 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 5 References 9 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 1 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 replaces GB/T 22750-2008 "High-purity alumina ceramic materials for surgical implants" and is consistent with GB/T 22750-2008. In addition to structural adjustments and editorial changes, the main technical changes are as follows. -- Added "Category 1.Tests required for periodic inspection" (see 4.2.2); -- Added "Category 2.Tests required by general material specifications" (see 4.2.3); -- Changed the material properties. Table 1 added the requirements for Young's modulus, fracture toughness, hardness, and cyclic fatigue. The volume density, Chemical composition, microstructure, material strength. and related indicators of wear performance (see 4.3, GB/T 22750-2008 Chapter 4); --Added sample preparation (see Chapter 5); --The microstructure test method has been changed, and the requirements for the number of specimens have been increased (see 6.3, 5.3 of GB/T 22750-2008); --Changed the strength performance test method, and added the four-point bending strength test and Weibull modulus test (see 6.4, GB/T 22750- 5.4 in.2008); --Added Young's modulus test method (see 6.5); --Added fracture toughness test methods, including SEVNB, SEPB and SCF test methods (see 6.6); -- Added hardness test method and adopted Vickers hardness test method (see 6.7); --Added cyclic fatigue test method (see 6.9). This document is modified to adopt ISO 6474-1.2019 "Ceramic materials for surgical implants - Part 1.High-purity alumina ceramic materials". The technical differences between this document and ISO 6474-1.2019 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); -- The normative reference GB/T 25995 replaced ISO 18754 to adapt to my country's technical conditions and increase operability (see 4.3, 6.1); --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 ASTM C1259 with the normative reference JC/T 2172 to adapt to my country's technical conditions and increase operability (See 4.3, 6.5); --ISO 16248 was replaced with the normative reference YY/T 1427 to adapt to my country's technical conditions and increase operability (See 6.9); --Added reference to GB/T 37248 and further clarified the test method (see 4.3 and 6.2); --The load for hardness test has been changed and the load requirements have been further clarified (see 6.7, 6.7 of ISO 6474-1.2019). The following editorial changes have been made to this document. --Replaced ISO 10993-1 with the informative reference GB/T 16886.1 (see Chapter 1, ISO 6474-1.2019 Chapter 1); --Added the description of periodic inspection and cited GB/T 2829 for informational purposes (see the note to 4.2.2); --YY/T 0651.1 replaced ISO 14242-1 (see 4.3, 6.8, 4.3 and 6.8 of ISO 6474-1.2019); --Added explanation on the method for measuring linear intercept of alumina grains (see Note 2 of 6.3). 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 Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC 110). This document was drafted by. Wuhan University of Technology, Shandong Weigao Orthopedic Materials Co., Ltd., and the State Food and Drug Administration for Medical Devices. Technical Review Center, Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Institute of Ceramics, Chinese Academy of Sciences, Yirui Biotechnology (Suzhou Zhou) Co., Ltd., Zhongnan Hospital of Wuhan University. The main drafters of this document are. Wang Xinyu, Lin Xiaoli, Lu Junqiang, Shi Xinli, Li Yuan, Wu Chunhui, Han Yingchao, Zhang Jiazhen, Duan Qingjiao, Wang Xingang, Wang Xiaofei, Cheng Bo, Zhang Xuexun, Zhao Siyu, and Cui Zhiqin. The previous versions of this document and the documents it replaces are as follows. --First published in.2008 as GB/T 22750-2008;

introduction

The 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. The properties of materials 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. The material has been shown in long-term clinical use to have an acceptable level of expected biological response if used appropriately. Ceramic materials for surgical implants Part 1.High purity alumina ceramic materials

1 Scope

This document specifies the properties of high purity alumina ceramic materials and describes the corresponding test methods. This document applies to bone spacers, bone replacement materials and orthopedic joint prosthetic components. This document does not include the content of biocompatibility evaluation (see GB/T 16886.1). 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 37248 High-purity alumina—Determination of trace metal elements—Inductively coupled plasma optical emission spectrometry 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 - Test method for equibiaxial bending strength at room temperature - 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) JC/T 2172 Test method for elastic modulus, shear modulus and Poisson's ratio of fine ceramics - Pulse excitation method YY/T 1427 Test solutions and conditions for static and dynamic corrosion testing of surgical implants, implantable materials and medical devices ISO 13383-1 Fine ceramics (advanced ceramics, high-tech ceramics) Microstructure characterization Part 1.Grain size and size distribution Determination of cloth [Fine ceramics (advanced ceramics, advanced technical ceramics)-Microstructural characteriza⁃ tion-Part 1.Determination of grain size and size distribution] ISO 17561 Fine ceramics (advanced ceramics, high-tech ceramics) Determination of elastic modulus of bulk ceramics at room temperature by acoustic resonance method Test method [Fine ceramics (advanced ceramics, advanced technical ceramics)-Test method for elastic moduli of monolithic ceramics at room temperature by sonic resonance] ISO 18756 Fine ceramics (advanced ceramics, high-tech ceramics) - Surface crack bending (SCF) method for the determination of the fracture toughness of bulk ceramics at room temperature Fracture toughness [Fine ceramics (advanced ceramics, advanced technical ceramics)-Determination of fracture toughness of monolithic ceramics at room temperature by the surface crack in flexure (SCF)method] ISO 23146 Fine ceramics (advanced ceramics, high-tech ceramics) - Test method for fracture toughness of bulk ceramics - Single-sided V-notch ......

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Question 1: How long will the true-PDF of GB/T 22750.1-2024_English be delivered?

Answer: Upon your order, we will start to translate GB/T 22750.1-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 22750.1-2024_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 22750.1-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version GB/T 22750.1-2024?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 22750.1-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.