Stainless Steel VS Titanium Cup, Real Person Evaluation, Video Final Truth Stunned! _ Thermos cup
Original Title: Stainless Steel VS Titanium Cup, Real Person Evaluation, Video Final Truth Stunned! Every November is always particularly depressed, not only to say goodbye to short skirts and hot pants, but also to face more and more fat loss, but the thermos cup can warm your heart and body in this winter, warm and fashionable, but also healthy, "official announcement" go a wave ~ Pure titanium cup, as the "handle" of the cup industry,titanium tubing price, still has considerable quality advantages and visual advantages, but is this pure titanium cup as good as it says? This may be the question of many people, "just talk without practice". Today, we will bring you a personal test of 0 distance (star rating mode,titanium round bar, number of ratings: 8 people). Today, we selected a thermos cup under the brand of Titanium, so that you can see the beauty of pure titanium water cup 360 degrees without dead angle. Let's go! 1. Unpack Advanced color matching and simple patterns, the outer packaging alone has already encircled me. Expand the full text The moment I took out the box, the artistic design had captured my heart, and I felt that my level had risen several levels immediately. 2. Visual comparison and evaluation of appearance The sense of design is absolutely "perfect" that can be felt without saying, and the inspiration from Monet's works has laid a good foundation for the overall visual effect. With the help of lines, titanium filler rod ,nickel titanium wire, this beauty has risen to another style, and drinking water, the most basic need of life, has become more ritualistic. Stainless steel thermos cups-The appearance color of stainless steel thermos cups on the market is mainly painted and filled. Although the single color is not so vulgar, it lacks artistic flavor, not to mention the complex design of those patterns. It is still difficult to drink a sense of sophistication. Scoring results 3. Comparative evaluation of tactile sensation As soon as I picked it up, I was surprised by the weight of the TAI pure titanium water cup, which is very light in shape and capacity, and has no heavy feeling of the general thermos cup. The touch is also excellent. Titanium gives up the consistent smooth and flowing water design, and chooses the surface of the cup body with a certain degree of convexity and concavity, so that users can not only feel the extraordinary superior feel, but also achieve the anti-skid effect, and there is no hot touch when using. Stainless steel thermos cup-The appearance of common stainless steel thermos cups is relatively uniform. Although some of them have anti-skid and anti-scald settings, they are all assisted by accessories. Although the function is added, the design sense is slightly deficient. Scoring results 4. Corrosivity comparison test As a cup made of pure titanium, it has absolute advantages in corrosion resistance. Titanium is an inert metal with stable chemical properties. It is difficult to oxidize or compound the reaction. It has excellent acid and alkali corrosion resistance and will not react with some high temperature, strong acid and strong alkali substances. Stainless steel thermos cup, stainless steel thermos cup is not rust-proof in the name, but it will not react significantly with other substances in the short term, but it will still precipitate metal and produce rust spots after long-term exposure to air, acid or alkaline substances. The following is the corrosion test of pure titanium cup and ordinary stainless steel thermos cup at TAI ℃. Previously, we compared the TAI ℃ pure titanium water cup with the stainless steel thermos cup from several different aspects. Apart from the outer packaging factors, it is not difficult to see the advantages of the TAI ℃ pure titanium water cup. The final evaluation comparison is as follows: This overwhelming advantage is not created out of thin air, people's demand for quality of life is gradually expanding,titanium tubing price, and this trend will naturally extend to all fields. The existence of pure titanium water cup is the embodiment of people's pursuit of quality-not only to meet the most basic needs, but also to reflect more spiritual values. For more titanium cup evaluation information, please follow the official account: TAICLIFE Return to Sohu to see more Responsible Editor:. yunchtitanium.com
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This is the footer for your site.Introduction to the US FDA Guideline "Key Points for Non-clinical Evaluation of Medical Devices Containing Nickel-Titanium Alloy" _ Characteristics
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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