What are the steps and key points of nuclear magnetic compatibility testing for medical devices?

Medical device MRI compatibility testing is a critical step to ensure the safe and effective use of medical devices in the MRI environment. As a professional medical device technical service platform, we, Tacteasy Epintek, have rich experience and professional technical strength in this field. Below, we will explain in detail the steps and key points of medical device NMR compatibility testing to demonstrate the advantages of Tacteasy Shanghai. Click on the link to get more suitable medical device program

I. Testing Steps

Project Preparation and Sample Evaluation

Collect detailed information about the medical device, including the structure, materials, and working principle.

Preliminary assessment of the medical device to determine its potential risk of NMR interference.

Test environment setup

Build an NMR compatibility test environment that complies with international standards, including MRI equipment, test instruments and measurement systems.

Ensure the stability of the test environment to minimize the impact of external interference on the test results.

Test sample placement and operation

Place the medical device in the MRI equipment to simulate the actual use scenario.

Normal use is performed according to the operating instructions of the medical device in order to observe its performance in the MRI environment.

Data collection and analysis

Using the test instrument to record the changes of various parameters of the medical device in the NMR environment, such as temperature and magnetic field strength.

The collected data is professionally analyzed to assess the NMR compatibility of medical devices.

Test report writing and review

Write a detailed test report based on the test results, including test steps, data analysis and conclusions.

The test report is reviewed by a professional team to ensure its accuracy and reliability.

II. Test Points

Safety Evaluation

Evaluate whether the medical device will produce unsafe phenomena such as overheating and displacement in the NMR environment.

Check whether the medical device will interfere with the normal operation of MRI equipment.

Performance assessment

Evaluate whether the performance of the medical device in the NMR environment will be affected, such as accuracy and stability.

Check whether the medical devices can work properly in the NMR environment and meet the clinical needs.

Compatibility assessment

Evaluate the compatibility of medical devices with MRI equipment, including compatibility with MRI equipment of different models and manufacturers.

Consider the versatility and adaptability of medical devices in multiple MRI environments.

Standard Compliance and Regulatory Requirements

Comply with international and domestic standards and regulatory requirements for medical device NMR compatibility.

To ensure that the testing process and results comply with industry standards, providing a strong guarantee for the safe use of medical devices.

With the above steps and points, Tacteasy Epintek is able to provide customers with professional and rigorous medical device NMR compatibility testing services. We have advanced testing equipment and a professional technical team to ensure the accuracy and reliability of the test results. At the same time, we have rich experience and deep industry background to provide comprehensive technical support and solutions for our clients. Shanghai Tacteasy has significant advantages and competitiveness in medical device NMR compatibility testing.