Original Title: Titanium Industry Overview and Development Trend Analysis 1. Basic information of titanium metal Titanium is considered a rare metal due to its scattered presence in nature and difficulty in extraction. However, it is relatively abundant, ranking tenth among all elements. Titanium ores, mainly ilmenite and rutile, are widely distributed in the crust and lithosphere. Titanium is also present in almost all organisms, rocks, water and soil. Extraction of titanium from primary ores requires either the Kroll or Hunt process. The most common compound of titanium is titanium dioxide, which is used to make white pigments. Other compounds include titanium tetrachloride (TiCl4) (used as a catalyst and to make smoke screens or skywriting) and titanium trichloride (TiCl3) (used to catalyze the production of polypropylene). Titanium and titanium alloys are widely used in aviation industry because of their low density, high strength, corrosion resistance, low temperature resistance, resistance, non-magnetic, non-toxic, tensile strength and other excellent properties, known as "space metal"; It is widely used in shipbuilding industry, chemical industry, manufacturing mechanical parts, telecommunication equipment, hard alloy and so on. Related Report: Analysis of Competition Pattern and Development Trend of Titanium Industry by Beijing Puhua Youce Information Consulting Co., Ltd. 2. Trade barriers (1) Technical barriers Titanium and titanium alloys can be widely used in civil, national defense, economy, science and technology and other fields, and the development of titanium industry to a certain extent also reflects the application level of a country's high-tech materials technology and the development of manufacturing industry, so the requirements for its quality stability, forging and rolling processing technology are relatively high. The smelting process of titanium includes: titanium slag smelting process, chlorination process, refining process, reduction distillation process and other links, and the technical difficulty of the links is high. In order to form large-scale and industrial production, it is necessary to solve the technical problems of process flow control and the management problems of the whole process flow, otherwise it will cause waste of resources and a substantial increase in production costs. In the future, the strategic significance of high-end titanium production will be more significant, and the shift of product structure to high-end will become an inevitable trend of its development. Domestic petrochemical, aerospace, electric power, marine engineering, sports and leisure industries continue to maintain strong demand for high-end titanium products, while high-tech industries such as computers are constantly emerging demand growth points for titanium, promoting the development of titanium products to high-end areas. The high-end development of domestic titanium industry has been supported by both policy and market orientation, and the national defense construction matching the improvement of economic strength will also promote the transfer of China's titanium industry to high-end areas and gradually improve the advantages of the industrial chain. Therefore, only by continuously improving technical indicators, developing energy-saving and environmental protection processes, and having core competitiveness in product quality, can enterprises achieve continuous development. As a result, the technical requirements of titanium and titanium alloy processing for enterprises in the industry will be higher and higher, which will constitute a higher technical barrier for enterprises entering later. (2) Policy barriers Expand the full text In the process of titanium processing, some processes need to use acid and alkali to clean the surface of the product, which produces some waste water and waste acid. At present, under the background of advocating "energy saving and environmental protection" in the whole society, with the continuous improvement of the national requirements for environmental protection, "energy saving and emission reduction" has become the leading direction of the future development of the whole industry in China, requiring enterprises entering the industry to have a strong sense of environmental protection and carry out production and operation according to the national environmental protection regulations. Reasonable post-treatment process and "three wastes" treatment steps are also very necessary. According to China's binding targets for energy conservation and emission reduction, the government will strictly control new projects, and some enterprises will be eliminated if they fail to meet the environmental protection standards. The environmental protection measures taken to meet the national environmental protection requirements and the corresponding investment in environmental protection equipment have set certain barriers for new entrants to the industry. (3) Capital barrier Titanium industry is a typical technology-intensive and capital-intensive industry, which usually requires a large amount of initial investment, including large-scale, high-standard processing plants, clean sites, a large number of technologically advanced cutting, forming, welding equipment and professional testing equipment and instruments. These essential factors of production require new entrants to the industry to invest a large amount of money at one time, which increases the investment risk and constitutes a capital barrier to enter the industry. In addition, due to the characteristics of the industry, the cost of raw materials accounts for a large proportion of operating costs, raw material procurement needs to occupy a large amount of funds, and the equipment products industry has a relatively long repayment cycle, which occupies a lar ger amount of liquidity, and further constitutes a capital obstacle for new entrants. (4) Customer trust barrier At present, titanium plate gr7 , the titanium and titanium alloy industry has developed to a certain extent, most customers have the concept of "first impressions first", downstream customers often choose their own trustworthy enterprises, such as long-term cooperative enterprises or brand excellent enterprises, first occupy the market will gain greater market advantages, new entrants will gain the trust of downstream customers. The cost of investment is more than that of early entrants, which often constitutes a barrier to entry for new entrants. 3. Development status of titanium industry in China Wujiang Group, the first titanium industry chain in China, with a total investment of 7.6 billion yuan, is closely linked from titanium ore to 20000 tons of titanium sponge and titanium processing, titanium alloy and titanium household products industry chain. Titanium ore resources in China mainly include ilmenite rock ore, ilmenite placer ore and rutile ore, which are mainly distributed in Sichuan, Hebei, Yunnan, Hainan and other places, of which 98. 9% is ilmenite and only about 1% is rutile. Although there are abundant titanium resources in China, and the reserves of primary ilmenite account for 94. 1% of the total amount of titanium ore, it belongs to the associated minerals of iron ore, and its development and utilization are restricted by the development and utilization of its main mineral-iron ore. Although after years of research, the comprehensive recovery rate of titanium resources can only reach about 26%, which is far behind that of developed countries. In addition, the proven reserves of rutile in China are not much, most of them are primary ore, and the grade is relatively low. Ilmenite placer and rutile in China account for a small proportion of titanium ore raw materials in terms of resource reserves and output. Titanium products are used in many important sectors of the national economy in China, and the operation of titanium industry is closely related to the development of the national economy. In 2016, the application of titanium resources in China was mainly concentrated in chemical industry, electric power, aerospace, metallurgy and other fields. In recent years, the scale of China's non-ferrous metal industry has been expanding, the industrial structure has been optimized, the quality level has been improved, and the ability of international operation has been enhanced, thus achieving rapid development. But at the same time, affected by the changes in the international and domestic economic situation, the market demand for non-ferrous metals is low, and the deep-seated contradictions and problems such as structural overcapacity and imbalance between supply and demand in the market accumulated over a long period of time in the non-ferrous metals industry have gradually emerged. Since 2014, the prices of major non-ferrous metal products have continued to fall. In 2015, the main business income of Enterprises above the scale of the non-ferrous metal industry increased by zero, and the total profit decreased by 13.2% compared with the same period last year. In order to solve the outstanding problems existing in the development of China's non-ferrous metals industry and promote the sustainable and healthy development of the non-ferrous metals industry, the State Council has formulated and promulgated the Guiding Opinions of the General Office of the State Council on Creating a Good Market Environment to Promote the Structural Adjustment, Transformation and Benefit Increase of the Non-ferrous Metals Industry, focusing on promoting the structural reform of the supply side, optimizing the stock and guiding. To ensure the sustained and healthy development of the industry. 4. Development trend of titanium industry in China Titanium industry belongs to the field of national strategic new materials. With the development of economy and the expansion of application fields, the demand will gradually increase in the future development of the industry. Temporary and structural overcapacity in the short term is a normal phenomenon. (1) Technical innovation of titanium products The development of domestic titanium industry benefits from the policy support of the state to the titanium industry. The Guiding Opinions of the General Office of the State Council on Creating a Good Market Environment to Promote the Structural Adjustment of Non-ferrous Metals Industry, Promoting Transformation and Increasing Benefits put forward the overall requirements, key tasks and policy guarantees for solving the outsta nding problems of China's non-ferrous metals industry and promoting the sustainable and healthy development of non-ferrous metals industry, and clearly demanded that technological innovation be strengthened and efforts be made. To meet the needs of advanced equipment, new generation information technology, ship and ocean engineering, aerospace, national defense science and technology and other fields. (2) Transfer of products to high-end fields Due to the low entry threshold of titanium industry in China, the competition of low-end titanium products is fierce. Therefore, the strategic significance of high-end titanium production is more significant, and the transfer of product structure to high-end has become an inevitable trend of its development. Domestic petrochemical, aerospace, electric power, marine engineering, sports and leisure industries continue to maintain strong demand for high-end titanium products, while high-tech industries such as computers are constantly emerging demand growth points for titanium, promoting the development of titanium products to high-end areas. At present, only 10% of titanium materials in China are used in high-end fields, while 50% of them are used in high-end fields abroad, which is a big gap. The high-end development of domestic titanium industry has been supported by both policy and market orientation, and the national defense construction matching the improvement of economic strength will also promote the transfer of China's titanium industry to high-end areas, and gradually improve the advantages of the industrial chain, which will be a long-term development process. It is an important task for the development of titanium industry in China to develop new functional titanium materials through the development of titanium strips, titanium and its alloy extrusion pipes to meet the needs of the overall construction of the country. (3) Titanium industry tends to be internationalized and scaled Due to the deepening of the Belt and Road Initiative, the trade between the East and the West has increased, and the integration of the East and West markets is forming a unified world titanium market. Since 1996, American Timet Company has merged British IMI Company and Cezus Company of Zirconium in Europe to control the European market, and also merged American A. Johnson Metals Company Limited,3d titanium wire, and merged with Valinox Pipe Company of France, the largest pipe manufacturing company in Europe. With the formation of the Valitimet joint venture, these acquisitions have significantly strengthened Timet. Return to Sohu to see more Responsible Editor:. yunchtitanium.com
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Original Title: Brief Introduction to the US FDA Guidelines on Key Points for Non-clinical Evaluation of Medical Devices Containing Nitinol Brief Introduction of FDA's Guideline on Nonclinical Evaluation of Medical Devices Containing Nitinol In October 2020, FDA of the United States issued the Guidelines for Non-clinical Evaluation of Medical Devices Containing Nitinol, which elaborated the key points of technical review of medical devices containing Nitinol. The contents of the Guidelines are briefly introduced as follows. I. Basic Concepts Nitinol is a near-equiatomic alloy of nickel and titanium, which has the properties of superelasticity and shape memory, and is widely used in cardiovascular devices such as heart stents, valves, guidewires, and other fields of medical devices. Compared with traditional metals such as stainless steel, titanium or cobalt-chromium alloys, nickel-titanium alloys have complex properties and are susceptible to many factors such as alloy composition, thermal processing, surface treatment, corrosion of biological tissues and so on. When evaluating its safety and effectiveness, it is necessary to focus on thermodynamic properties, process sensitivity and so on. II. Key points of technical evaluation (I) Basic information 1. Material composition If the material of the nickel-titanium alloy used in the device conforms to a recognized standard, it shall be specified in the application (e.g., ASTM F2063). If the material does not conform to a recognized standard,titanium plate gr7, the composition of the material shall be defined and its properties shall be described. 2. Manufacturing process The production process flow diagram shall be provided, especially the thermal process, surface treatment steps, final cleaning steps, etc. 3. Superelastic/shape memory properties At operating temperatures, superelasticity or shape memory can be achieved by adjusting the composition and heat treatment of the nitinol alloy. Due to the large difference in properties between the two, the applicant should specify in the application which properties (superelasticity or shape memory) of the nickel-titanium alloy are used. 4. Deformation temperature The change of temperature will affect the mechanical property of nickel-titanium alloy. It is recommended to specify the phase transformation temperature of the finished product in the data. Refer to ASTM F2004 and ASTM F2082. (II) Mechanical test 1. Key points of experiment It is recommended to explain the control mode adopted for mechanical testing; for deformable implantable devices,3d titanium wire, it is recommended to consider clinical deformation and temperature drift before mechanical testing; mechanical testing should be carried out at actual clinical temperature; if fatigue testing is carried out, it is recommended to use clinically relevant solvents (such as PBS); If the shape memory properties of the device are utilized, it is recommended that shape memory testing be performed at clinical temperatures and service cycles, and that functional properties and device integrity be evaluated. 2. Stress calculation/strain analysis If a computational analysis is performed, an appropriate metal model should be used to correctly reflect the thermodynamic properties of the nitinol alloy. A material model may be selected by reference to ASTM F2516. The applicant shall verify the calculation model. If the device is subjected to a cyclic load test, the fatigue safety factor shall also be calculated. Expand the full text (III) Corrosion resistance test 1. Pitting Corrosion of nitinol alloys can result in the release of nickel ions and affect the integrity of the device. The corrosion resistance depends on the manufacturing process and surface treatment. Pitting corrosion testing is recommended in accordance with ASTM F2129. 2. Release of nickel ion If Nitinol devices do not meet the accepted criteria for corrosion resistance, or do not use a proven surface treatment process, a nickel ion release test should be considered. Refer to ASTM F3306 for test methods. 3. Galvanic corrosion If Nitinol devices are expected to be in contact with dissimilar metals, consideration should be given to performing a galvanic corrosion test, as recommended in ASTM F3044. (IV) Biocompatibility It is recommended to refer to ISO 10993 -1 for biocompatibility evaluation. If a nickel ion release test is performed, refer to ISO 10993 -17. (V) Label information It is recommended that the label clearly indicate that the device contains nitinol, suggesting that it may cause allergic reactions in patients, nickel titanium wire ,Titanium welding pipe, especially in long-term or permanent implanted devices. III. References: [1] FDA. Technical Considerations for Non-Clinical Assessment of MedicalDevices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff. October 15, 2020 Labels: Medical Device FDA Registration, US Medical Device GMP Certification Release date: 2021-07-06 20:07 Views: 27 In October 2020, FDA of the United States issued the Guidelines for Non-clinical Evaluation of Medical Devices Containing Nitinol, which elaborated the key points of technical review of medical devices containing Nitinol. The contents of the Guidelines are briefly introduced as follows. Brief Introduction of FDA's Guideline on Nonclinical Evaluation of Medical Devices Containing Nitinol In October 2020, FDA of the United States issued the Guidelines for Non-clinical Evaluation of Medical Devices Containing Nitinol, which elaborated the key points of technical review of medical devices containing Nitinol. The contents of the Guidelines are briefly introduced as follows. I. Basic Concepts Nitinol is a near-equiatomic alloy of nickel and titanium, which has the properties of superelasticity and shape memory, and is widely used in cardiovascular devices such as heart stents, valves, guidewires, and other fields of medical devices. Compared with traditional metals such as stainless steel, titanium or cobalt-chromium alloys, nickel-titanium alloys have complex properties and are susceptible to many factors such as alloy composition, thermal processing, surface treatment, corrosion of biological tissues and so on. When evaluating its safety and effectiveness, it is necessary to focus on thermodynamic properties, process sensitivity and so on. II. Key Points of Technical Evaluation (I) Basic information 1. Material composition If the material of the nickel-titanium alloy used in the device conforms to a recognized standard, it shall be specified in the application (e.g., ASTM F2063). If the material does not conform to a recognized standard, the composition of the material shall be defined and its properties shall be described. 2. Manufacturing process The production process flow diagram shall be provided, especially the thermal process, surface treatment steps, final cleaning steps, etc. 3. Superelastic/shape memory properties At operating temperatures, superelasticity or shape memory can be achieved by adjusting the composition and heat treatment of the nitinol alloy. Due to the large difference between the two properties, the applicant should specify in the application which property (superelasticity or shape memory) of the nickel-titanium alloy is used. 4. Deformation temperature The change of temperature will affect the mechanical property of nickel-titanium alloy. It is recommended to specify the phase transformation temperature of the finished product in the data. Refer to ASTM F2004 and ASTM F2082. (II) Mechanical test 1. Key points of experiment It is recommended to explain the control mode adopted for mechanical testing; for deformable implantable devices, it is recommended to consider clinical deformation and temperature drift before mechanical testing; mechanical testing should be carried out at actual clinical temperature; if fatigue testing is carried out, it is recommended to use clinically relevant solvents (such as PBS); If the shape memory properties of the device are utilized, it is recommended that shape memory testing be performed at clinical temperatures and service cycles, and that functional properties and device integrity be evaluated. 2. Stress calculation/strain analysis If a computational analysis is performed, an appropriate metal model should be used to correctly reflect the thermodynamic properties of the nitinol alloy. A material model may be selected by reference to ASTM F2516. The applicant shall verify the calculation model. If the device is subjected to a cyclic load test, the fatigue safety factor shall also be calculated. (III) Corrosion resistance test 1. Pitting Corrosion of nitinol alloys can lead to the release of nickel ions and affect the integrity of the device. The corrosion resistance depends on the manufacturing process and surface treatment. Pitting corrosion testing is recommended in accordance with ASTM F2129. 2. Release of nickel ion If Nitinol devices do not meet the accepted criteria for corrosion resistance or do not use a proven surface treatment process, a nickel ion release test should be considered. Refer to ASTM F3306 for the test method. 3. Galvanic corrosion If Nitinol devices are expected to be in contact with dissimilar metals, consideration should be given to performing a galvanic corrosion test, as recommended in ASTM F3044. (IV) Biocompatibility It is recommended to refer to ISO 10993 -1 for biocompatibility evaluation. If a nickel ion release test is performed, refer to ISO 10993 -17. (V) Label information It is recommended that the label clearly indicate that the device contains nitinol, suggesting that it may cause allergic reactions in patients,titanium bar gr5, especially in long-term or permanent implanted devices. III. References: [1] FDA. Technical Considerations for Non-Clinical Assessment of MedicalDevices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff. October 15, 2020 Tags: Medical Device FDA Registration, US Medical Device GMP Certification Return to Sohu to see more Responsible Editor:. yunchtitanium.com
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