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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1812-2022: Characterization of physical and chemical properties of degradable biomedical metallic materials Status: Valid
Basic dataStandard ID: YY/T 1812-2022 (YY/T1812-2022)Description (Translated English): Characterization of physical and chemical properties of degradable biomedical metallic materials Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30 Word Count Estimation: 9,977 Issuing agency(ies): State Drug Administration YY/T 1812-2022: Characterization of physical and chemical properties of degradable biomedical metallic materials---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. Characterization of physical and chemical properties of degradable biomedical metallic materials ICS 11.100.20 CCSC30 People's Republic of China Pharmaceutical Industry Standard Characterization of physicochemical properties of degradable biomedical metal materials Published on 2022-05-18 2023-06-01 Implementation Released by the State Drug Administration forewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248). This document was drafted by. Shandong Medical Device Product Quality Inspection Center, Peking University, Suzhou Oriji Medical Technology Co., Ltd., Yuan Heart Technology (Shenzhen) Co., Ltd. The main drafters of this document. Shi Yanping, Lu Wenbo, Wan Min, Zheng Yufeng, Zhang Xiaonong, Zhang Deyuan, Liu Lili, Zhang Shaoxiang, Li Yunfei, Xia Dandan and Shen Yong.IntroductionIn clinical applications, non-degradable metal materials may suffer from long-term biocompatibility or require secondary surgical removal. degradable The mechanical properties of polymer materials are relatively low, which limits their use in some fields. Degradable biomedical metal materials have Degradability and excellent mechanical properties are more and more widely used in bone nails, stents, closure clips and other devices. At present, the relevant standards for metal materials that have been published, such as GB/T 13810, GB 4234, etc., are mostly aimed at non-degradable metal materials. for The product standard for a device in a specific field does not evaluate the physicochemical properties of degradable metal materials and devices. Degradable metal material The prepared device will degrade during use, and with the extension of the implantation time, the metal or additives inside the material will be separated in the form of ions. Compared with traditional materials, in addition to mechanical properties, we should also pay attention to the evaluation of their safety. When choosing a degradable metal material, in addition to considering whether the physical and chemical properties of the material are suitable for the purpose of use of the device, it is also necessary to combine its clinical Design the degradation cycle for the intended use of the bed, considering whether the degradation process has the clinically required mechanical properties and the biological safety of the degradation products. Wholeness. The evaluation of the degradation performance of biodegradable biomedical metal materials includes two approaches, in vitro and in vivo. This document mainly deals with in vitro degradation tests. The in vivo degradation test may involve more influencing factors, and the specific test protocol design can refer to the applicable principles and contents in this document. Characterization of physicochemical properties of degradable biomedical metal materials1 ScopeThis document specifies the characterization of physical and chemical properties of degradable biomedical metal materials (hereinafter referred to as degradable metal materials). This document applies to degradable biomedical metal materials. Note. Based on the current market situation, degradable biomedical metal materials mainly include magnesium, iron and zinc metals and their alloys.2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB/T 6394 Metal Average Grain Size Determination Method3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 A kind of biomedical metal material that can be gradually corroded and degraded in the body. NOTE. The body host response to corrosion products released during the degradation of such materials is appropriate, the products can pass through cells and/or tissues or be absorbed by cells and/or Or tissue metabolism or assimilation. Degradable metal materials assist the body to complete its intended use without residue.4 Requirements4.1 Chemical composition The chemical composition of degradable metal materials should be characterized in accordance with recognized analytical methods, in line with the requirements of its claims or the provisions of the corresponding standards. Various components of degradable metal materials will be released into the body with degradation, and the manufacturer should specify the limit value of each component to meet the safety requirements. sexual requirements. 4.2 Surface Quality Surface quality (such as surface roughness, presence of cracks, burrs, burrs and other defects) will affect its performance or degradation rate, Therefore, attention should be paid to the influence of the processing process on the appearance and surface roughness of metal materials. If applicable, the surface quality can be observed under a magnifying glass of a certain multiple, and the surface of the degradable metal material can be observed for dirt, cracks, concave or not. Defects such as pits, deformations, scratches, burrs and burrs, the surface roughness should meet the design requirements. 4.3 Internal quality If there are pores, shrinkage holes or porosity inside the degradable metal material, it will affect the degradation rate or performance of the material. If applicable, may Non-destructive testing methods such as X-ray inspection or ultrasonic flaw detection are used to test the internal quality of the material. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1812-2022_English be delivered?Answer: Upon your order, we will start to translate YY/T 1812-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1812-2022_English with my colleagues?Answer: Yes. 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