T/CSBM 0018-2021 Active Group standards

T/CSBM 0018-2021 The test method for shape recovery capacity of self-expandable vascular stents made of nickel-titanium shape memory alloys

Publish Date: 2021-04-26 Implement Date: 2021-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBM 0018-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2021-04-26

Implement Date: 2021-10-01

Pages: 8 pages

Scope

Main Technical Content: Technical Requirements: 1. Material samples shall comply with GB 24627, *Nickel-Titanium Shape Memory Alloy Processing Materials for Medical Devices and Surgical Implants*, and the corresponding requirements for self-expanding nickel-titanium materials for vascular stents. 2. Test samples: Self-expanding nickel-titanium shape memory alloy vascular stents that meet the testing requirements. 3. Methods and Principles 3.1 Af Temperature Test (BFR) 3.1.1 Experimental Principle The test sample is cooled to a fully martensitic phase, and after deformation, it is heated to a fully austenitic phase at high temperature. During heating, due to the martensite phase transformation, the shape of the sample changes. By measuring the deformation displacement of the sample with temperature, a temperature-displacement curve is plotted, and the Af temperature is determined by the tangent method on the temperature-diameter (or displacement) curve. 3.1.2 Instruments and Reagents 3.1.2.1 Af Point Test Instrument: The principle, displacement sensor, and thermocouple meet the requirements of ASTM F2082M. 3.1.2.2 Recovery Fixture. 3.1.2.3 Magnetic Stirrer. 3.1.2.4 All testing equipment is within the calibration period. 3.1.3 Experimental Steps 3.1.3.1 Pour cooling medium into a container that can submerge the test sample. For room-temperature superelastic shape memory alloys, the cooling medium temperature should be below -55°C; for room-temperature martensitic alloys, the cooling medium temperature should be below 10°C. 3.1.3.2 Place the corresponding magnetic stirrer, sample, and sample stage in the cooling medium in 3.1.3.1. 3.1.3.3 Place the container on the heating platform corresponding to the Af point test instrument. 3.1.3.4 Squeeze the sample to a diameter change of at least 50% or directly release it through the loading sheath. 3.1.3.5 Heat and stir the thermal conductivity medium at a heating rate of no more than 4°C/min.