Dimensions of titanium rods, plates, tubes, and wires specify _ length
Original Title: Dimensional Specifications for Titanium Bars, Plates, Tubes, and Wires Dimensional specifications for titanium rods, plates, tubes and wires The dimension of titanium is one of the basic knowledge of titanium. The dimension of titanium generally refers to the length of titanium. The length of titanium mainly includes length, width, height, diameter, radius,6al4v titanium bar, inner diameter, outer diameter and wall thickness. The length of titanium is measured in meters (m), centimeters (cm), millimeters (mm),Titanium 6Al4V wire, and so on. They need to understand titanium materials, including titanium rods, titanium plates, titanium tubes, titanium wires and so on, which are rolled from titanium and titanium alloys. Expand the full text 1. Size determination of titanium material It is a useful way to save information. Scale sizing means that the length or length multiplied by width is not less than a certain scale, or the length of titanium plate. Length by width from how many to how many dimensions within the scale of delivery. The production unit can produce and supply according to the demand of this scale. 2. No fixed length It refers to the general length, titanium round bar ,ti6al4v eli, where the product scale (length or width) is within the standard and regular scale, and does not require a fixed scale, it is called an indefinite scale. Indefinite length is also called general length. Metal materials delivered to indefinite length, as long as they are delivered within a regular length scale. For example, if the general length rule of general round titanium not larger than 25mm is 4-10m, the round titanium with length within this scale can be delivered. 3. Fixed length Cut to a fixed size according to the order requirements is called fixed length. When the goods are delivered according to the fixed length, the delivered metal data must have the length specified by the buyer in the order contract. For example, if it is specified in the contract that the goods shall be delivered according to the fixed length of 5m, the delivered materials must be 5m long, and those shorter than 5m or shorter than 5m are unqualified. But in fact, the delivery can not be 5 meters long, so the rule allows positive error, but not negative error. 4. Double scale If it is cut into an integral multiple according to the fixed scale of the order demand, it is called a multiple scale. When the goods are delivered in multiple lengths, the length of the delivered metal material must be an integral multiple (plus a saw cut) of the length (called a single length) specified by the demander in the order contract. For example, if the demander requires a single length of 2m in the order contract, then the length is 4m when it is cut into double lengths, and 6m when it is cut into triple lengths, plus one or two saw cuts separately. The amount of kerf is regulated in the specification. When multiple ruler delivers goods, allow to have positive error only, do not allow to present negative deviation value. 5. Narrow ruler If the width is less than the lower limit of the irregular width of the standard rule, but not less than the narrowest width allowed, it is called a narrow ruler. When delivering goods in narrow sizes, it is necessary to pay attention to the narrow size share and the narrowest size of the relevant normative rules. 6. Short ruler If the length is less than the lower limit of the indefinite length of the titanium tube specification, but not less than the shortest length allowed,titanium tubing price, it is called a short ruler. For example, the rule in the specification of titanium pipes for water and gas transportation allows 10% (calculated according to the number of pipes) of short titanium pipes with a length of 2-4m in each batch. 4m is the lower limit of indefinite length, and the shortest length allowed is 2m. 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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