T/CSBM 0013-2021 Active Group standards

T/CSBM 0013-2021 Endovascular stent MRI compatibility and RF heating test method

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 0013-2021

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: 22 pages

Scope

Main Technical Content: 1. Overview of Test Methods: 1.1 The straight-tube vascular stent to be tested is placed in a phantom material that simulates the electrical and thermal properties of the human body. The location of the straight-tube vascular stent should have typical irradiation conditions, which can be characterized by evaluating the local SAR value. The phantom material is a saline gel made from saline and a gelling agent. Temperature probes should be placed at both ends of the straight-tube vascular stent. The phantom is placed in an MRI system or a device capable of generating similar radiofrequency (RF) fields. The RF field is applied for approximately 15 minutes or any period sufficient to characterize temperature elevation and local SAR values. The RF field should be sufficient to generate an average whole-body SAR value of approximately 2 W/kg in the phantom. 1.2 The test process consists of two steps: - Step 1: During the 15-minute RF irradiation, the temperature elevation at both ends of the straight-tube vascular stent is measured using fiber-optic temperature measurement probes (or similar technology) and the reference location. - Step 2: After removing the straight-tube vascular stent, the temperature elevation at the same locations as in Step 1 is measured under the same RF irradiation conditions. All tests should be conducted under the stent's fixation device. The local SAR values are calculated based on the measured temperatures at each probe location and the reference location. The local SAR value at the reference location is used to verify the consistency of the RF irradiation conditions applied in Steps 1 and 2. 2 Equipment 2.1 Test Device The test device consists of an appropriate phantom and an MRI system or MRI testing system used to generate RF fields. The phantom, straight-tube vascular stent, and MRI testing system are used to simulate the electrical and physiological environments of patients and devices during