T/CSBM 0015-2021 Active

Main technical content: 1. Material requirements: The product materials shall comply with GB24627 *Nickel-Titanium Shape Memory Alloy Processing Materials for Medical Devices and Surgical Implants* and the corresponding technical requirements for bone plates. 2. Sample requirements: 2.1 Test products using bone plate products. If the bone plate products cannot meet the requirements, simulated samples can be used instead. If the structure of the product is similar to that of the simulated samples, the test methods of the simulated samples can be used for testing. The raw materials used for the simulated samples should be from the same batch as those of the products being replaced, and the mechanical processing and treatment processes should be consistent. 2.2 The simulated samples are divided into open-ring shapes and long strip shapes, with size requirements as shown in Figures 1 and 2. 2.3 All performance indicators, processing methods, process flow, and inspection standards of the simulated samples shall be consistent with the product requirements. Note: "Units: mm. If no tolerance is specified, it shall follow the coarse C grade in GB/T 1804-2000." Note: The thickness D = 0.20 mm to 2.50 mm, the width (A) is 5 to 10 times the thickness (D), and the length (L) is not less than 1.5 times the circumference of the test mandrel. If no tolerance is specified, it shall follow the precision F grade in GB/T 1804-2000.