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 tubing price, 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