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YY/T 0811-2021: Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0811: Historical versions
Similar standardsYY/T 0811-2021: Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications---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/YYT0811-2021 YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.40 C 35 Replacing YY/T 0811-2010 Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications Issued on. SEPTEMBER 06, 2021 Implemented on. SEPTEMBER 01, 2022 Issued by. National Medical Products Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative references... 4 3 Terms and definitions... 6 4 Sampling... 6 5 Relevant requirements for extensively crosslinked UHMWPE products... 6 6 Biocompatibility... 8 Annex A (informative) Basic principle... 9 Bibliography... 11ForewordThis Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces YY/T 0811-2010 "Standard guide for extensively irradiation. Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications". Compared with YY/T 0811-2010, in addition to the editorial modifications, the main technical changes in this Standard are as follows. -- Add the requirements for modulus of elasticity (see Table 1 of this Edition); -- Modify the test methods for compressive modulus and thermal properties (see Table 1 of this Edition; Table 1 of Edition 2010); -- For small punching limit load, trans vinylidene index (TVI) test method, the ASTM standard is replaced by the converted industry standard (see Table 2 of this Edition; Table 1 of Edition 2010); -- Adjust the position of electron spin resonance in the standard (see 5.2.3 of this Edition; Table 1 of Edition 2010); -- Add the requirements for preclinical simulations (see 5.2.4 of this Edition). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Standard was proposed by National Medical Products Administration. This Standard shall be under the jurisdiction of Subcommittee on Orthopedic Implants of National Technical Committee on Surgical Implants and Orthopedic Devices of Standardization Administration of China (SAC/TC 110/SC 1). The drafting organizations of this Standard. Tianjin Medical Device Quality Supervision and Inspection Center, Medical Device Technology Evaluation Center of the State Drug Administration, Kuajun Plastic Trading (Shanghai) Co., Ltd., Stryker (Beijing) Medical Devices Co., Ltd., Zimmer (Shanghai) Medical International Trade Co., Ltd. Main drafters of this Standard. Jing Ming, Liu Bin, Gao Jintao, Ma Chunbao, Zhu Jinqing, Yang Xiuyun, Zhang Haiming, Wang Yuhai. Version of standard substituted by this Standard is. -- YY/T 0811-2010. Extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications1 ScopeThis Standard specifies relevant requirements and test methods for irradiation- crosslinked (extensively crosslinked) ultra-high molecular weight polyethylene fabricated (UHMWPE) forms for surgical implant applications. This Standard is applicable to pure resin powder required by GB/T 19701.1 or extensively irradiation-crosslinked UHMWPE products produced by molding compounds required by GB/T 19701.2.This Standard is only applicable to UHMWPE products that have been extensively irradiated by γ rays and electron beam ionizing radiation sources. This Standard does not apply to UHMWPE that has only been treated with gas plasma, ethylene oxide or ionizing radiation with a dose of less than 40kGy, that is, materials that have undergone routine sterilization only. NOTE 1.The exact relationship between the mechanical properties of the above articles and the in vivo performance has not been established. Although scientists are devoted to the study of the relationship between polymer structure, polymer properties and polymer design, the above relationship has not been satisfactorily explained. The following mechanical tests are commonly used to assess the repeatability of manufacturing procedures and are suitable for comparative studies of different materials. NOTE 2.The following warning text applies only to the test method part of Chapter 5.This Standard does not attempt to describe all the safety issues involved, even those related to its use. It is the responsibility of the user of this Standard to establish appropriate safety and operating practices, and to clarify the applicability of regulatory limitations prior to application.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 16886.1, Biological evaluation of medical devices -- Part 1.Evaluation and testing within a risk management process GB/T 16886.2, Biological evaluation of medical devices -- Part 2.Animal welfare requirements GB/T 16886.3, Biological evaluation of medical devices -- Part 3.Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.4, Biological evaluation of medical devices -- Part 4.Selection of tests for interactions with blood GB/T 16886.5, Biological evaluation of medical devices -- Part 5.Tests for in vitro cytotoxicity GB/T 16886.6, Biological evaluation of medical devices -- Part 6.Tests for local effects after implantation GB/T 16886.7, Biological evaluation of medical devices -- Part 7.Ethylene oxide sterilization residuals GB/T 16886.9, Biological evaluation of medical devices -- Part 9.Framework for identification and quantification of potential degradation products3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply. 3.1 UHMWPE fabricated form UHMWPE of any shape made of pure polymer powder for surgical implants before crosslinking, packaging and sterilization. 3.3 ionizing radiation γ rays or high-energy electron radiation. 3.4 crosslinking The process of generating chemical bonds between UHMWPE molecular chains by ionizing radiation.4 SamplingIf applicable, each batch of powder and products shall be determined according to the requirements of this Standard.5 Relevant requirements for extensively crosslinked UHMWPE products5.1 Requirements for synthetics The powder and molding compound for manufacturing extensively crosslinked UHMWPE materials shall meet the requirements of GB/T 19701.1 and GB/T 19701.2. 5.2 Physical requirements 5.2.1 There are many production methods for extensively crosslinked UHMWPE materials, so different manufacturers of this material have developed their own proprietary production methods and processes. 5.2.3 Table 2 (Mechanical and physical evaluation, Part 2) lists the suitable test items and corresponding test methods for extensively crosslinked UHMWPE. Other test items, such as electron spin resonance, may also be considered based on literature and theoretical analysis (see Annex A). 5.2.4 It is recommended that functional testing based on simulated clinical functions and known failure modes be considered for extensively crosslinked UHMWPE end product components.6 BiocompatibilityThe results of long-term clinical trial studies show that the biological reactions that occur when using this material are at an acceptable level.Annex A(informative) Basic principle A.1 This standard aims to provide the minimum necessary test methods for determining the physical, chemical and mechanical properties of radiation extensively crosslinked UHMWPE materials for orthopedic or spinal implants. A.2 One of the purposes of this Standard is to provide guidance to regulatory authorities and surgical implant manufacturers through a set of standard test methods for determining the characteristics of extensively crosslinked UHMWPE materials. A.3 Even though it is now possible to identify test methods for characterizing extensively crosslinked UHMWPE, it is still not possible to specify acceptable minimum values for each test method. Because in most of the above-mentioned test methods, the correlation between the measured properties of the material and the clinical performance is currently unknown. Therefore, material manufacturers are required to formulate minimum standards for the production process of their extensively crosslinked UHMWPE materials. At the same time, use the test methods provided by this Standard to verify the production process. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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