GB/T 19701.3-2024 English PDFUS$199.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 19701.3-2024: Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods Status: Valid
Basic dataStandard ID: GB/T 19701.3-2024 (GB/T19701.3-2024)Description (Translated English): Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 10,178 Date of Issue: 2024-11-28 Date of Implementation: 2025-12-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 19701.3-2024: Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods---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 Standard of the People's Republic of China Ultra-high molecular weight polyethylene for surgical implants Part 3.Accelerated aging methods (ISO 5834-3.2019,MOD) Released on 2024-11-28 2025-12-01 Implementation State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Categories 1 5 Materials 2 6 Instruments and test samples 2 7 Instrument Calibration 2 8 Status Adjustment 2 9 Significance and Use 2 10 Steps to Accelerated Aging 3 11 Report 3 References 4ForewordThis 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. This document is part 3 of GB/T 19701 Ultra-high molecular weight polyethylene for surgical implants. GB/T 19701 has been published The following parts. --- Part 1.Powders; --- Part 2.Moulding materials; --- Part 3.Accelerated aging methods; --- Part 5.Morphological evaluation method. This document is modified to adopt ISO 5834-3.2019 "Ultra-high molecular weight polyethylene for surgical implants - Part 3.Accelerated ageing methods". This document has the following structural adjustments compared to ISO 5834-3.2019. ---11.2~11.5 correspond to 11.1~11.4 in ISO 5834-3.2019. The technical differences between this document and ISO 5834-3.2019 and their reasons are as follows. --- ISO 5834-2 (see Chapter 4 and Chapter 5) has been replaced by the normative reference GB/T 19701.2 to adapt to the technical requirements of my country. Improve operability; --- The normative reference GB/T 21461.1 replaces ISO 11542-1 (see Chapter 3) to adapt to my country's technical conditions and provide High operability; --- ISO 11542-2 (see Chapter 3) has been replaced by the normative reference GB/T 21461.2 to adapt to my country's technical conditions and provide High operability; --- ASTM F.2003..2015 was replaced by the normatively referenced ASTM F.2003.2022 (see Chapters 6 to 8, Chapter 10 Chapter), due to the updated version of the referenced standard. The following editorial changes were made to this document. --- Replaced the informative reference ISO 14242 (all parts) with YY/T 0651 (all parts) (see Chapter 9); --- Replaced the informative reference ISO 14243 (all parts) with YY/T 1426 (all parts) (see Chapter 9). 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/TC110). This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Antong Yitai Medical Technology Co., Ltd., Beijing Mengtai Yin Medical Equipment Co., Ltd. and Stryker (Beijing) Medical Equipment Co., Ltd. The main drafters of this document are. Zhang Wang, Wang Xiangyu, Li Libin, Zhang Keyan, Hu Zhijie, Tian Qiushi, Xu Zhiyong, Chen Wenjun, Ji Huizhuo, and Wang Tao.IntroductionUltra-high molecular weight polyethylene has good mechanical properties, wear resistance and biocompatibility, and is widely used in surgical implants such as artificial joints, Widely used in scaffold products. GB/T 19701 "Ultra-high molecular weight polyethylene for surgical implants" is planned to consist of 5 parts. --- Part 1.Powders. The purpose is to standardize the requirements and corresponding tests of ultra-high molecular weight polyethylene powders for surgical implants method. --- Part 2.Moulding materials. The purpose is to specify the requirements and related The method should be tested. --- Part 3.Accelerated aging method. The purpose is to provide ultra-high molecular weight polyethylene (UHMWPE) materials for surgical implants Test method for oxidative stability during processing and sterilization. --- Part 4.Oxidation index test method. The purpose is to provide a test method for the relative oxidation degree of ultra-high molecular weight polyethylene. Evaluation of the relative degree of oxidation of ultra-high molecular weight polyethylene. --- Part 5.Morphology evaluation method. The purpose is to provide a morphology quality test method for ultra-high molecular weight polyethylene molding compounds to evaluate Relative cure qualities (morphology) of ultra-high molecular weight polyethylene molding compounds. Ultra-high molecular weight polyethylene for surgical implants Part 3.Accelerated aging methods1 ScopeThis document describes the oxidative stability of ultra-high molecular weight polyethylene (PE-UHMW) materials for surgical implants during processing and sterilization. test method. This document describes a method for accelerated aging of PE-UHMW specimens and components for total joint prostheses. The materials were aged under conditions to accelerate oxidation and thus assess their potential long-term chemical and mechanical stability.2 Normative referencesThe contents of the following documents constitute 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 19701.2 Ultra-high molecular weight polyethylene for surgical implants Part 2.Moulding materials (GB/T 19701.2-2024, ISO 5834-2.2019,MOD) GB/T 21461.1 Plastics Ultra-high molecular weight polyethylene (PE-UHMW) molding and extrusion materials Part 1.Nomenclature system and Classification basis (GB/T 21461.1-2023, ISO 21304-1.2019, MOD) GB/T 21461.2 Plastics Ultra-high molecular weight polyethylene (PE-UHMW) molding and extrusion materials Part 2.Sample preparation and Performance measurement (GB/T 21461.2-2023, ISO 21304-2.2021, MOD) ASTM F2003.2022 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma-Ray Irradiation in Air tioninAir)3 Terms and definitionsThe terms and definitions defined in GB/T 21461.1, GB/T 21461.2 and the following apply to this document. The terminology databases used for standardization maintained by ISO and IEC are located at. 3.1 Oxidation Oxygen is introduced into the molecule [eg, ultra-high molecular weight polyethylene (PE-UHMW)] via chemical covalent bonds.4 CategoriesThe test samples for accelerated aging should be made of Type 1, Type 2 or Type 3 PE-UHMW molding compounds specified in GB/T 19701.2. manufacture. NOTE. Type 3 polymers are no longer manufactured. However, to cover existing reserves in inventory, Type 3 material is retained in this document until the next revision. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 19701.3-2024_English be delivered?Answer: Upon your order, we will start to translate GB/T 19701.3-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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