T/CSBM 0017-2021 Active Group standards

T/CSBM 0017-2021 Evaluation method for shape recovery performance of nickel-titanium shape memory alloy heart closure device

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 0017-2021

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: 12 pages

Scope

Main Technical Content: Technical Requirements: 1.1 General Provisions 1.1.1 The evaluation of the shape recovery performance of cardiac occluders shall be conducted in accordance with this document, and the results shall be evaluated. 1.1.2 The evaluation of the shape recovery performance of cardiac occluders shall consider at least the following aspects: a) The testers shall have a certain professional background and be trained in test methods and equipment use. b) The testing instruments (temperature, stress, strain) and various sensors shall be calibrated and verified. c) The samples to be tested shall be normal finished products or samples processed by equivalent processes. d) The testing environment shall be as consistent as possible with the implantation environment, such as temperature, body fluids, and models. Note: To ensure the consistency of the evaluation of the shape recovery performance of cardiac occluders, it is recommended to use the evaluation method provided in this document. If the method used is inconsistent with the guidance provided in this document, the rationale for its appropriateness shall be explained. 1.2 The evaluation of the shape recovery performance of cardiac occluders shall consider at least the following aspects: a) The characteristics of the nickel-titanium material used in the cardiac occluders; b) The intended use of the cardiac occluders and their interaction with tissues; c) The influence of the physiological environment in which the cardiac occluders are intended to be used (e.g., temperature, body fluids, etc.). 2. Af Temperature Test Method 2.1 Test Principle The specimen is cooled to a fully martensitic phase state, and the specimen is deformed after heating to a fully high-temperature austenitic phase state. During the heating process, due to the martensite phase transformation, the shape of the specimen changes. By measuring the deformation amount (e.g., displacemen