MRI Compatibility Tests

What is MRI Compatibility Testing? MRI compatibility testing is designed to evaluate the potential risks posed by medical devices when used in MRI environments. These tests help determine whether a device is safe for MRI use and under what specific conditions it can be safely operated. Particularly in the case of implanted medical devices, the risks can be significant and include magnetic attraction, induced torque, radiofrequency (RF) heating, and imaging artifacts.

According to ASTM (American Society for Testing and Materials) standards, the primary risks include:

  • Magnetically Induced Displacement Forces

  • Magnetically Induced Torque

  • RF-Induced Heating

  • MRI Image Artifacts

Such risks can compromise the functionality of an implant or cause harm such as tissue burns or mechanical damage. Even passive implants, which are not electrically active (e.g., pacemakers), can interact with the MRI field. Beyond safety concerns, implants may distort MRI images, resulting in diagnostic artifacts that limit clinical usability.

Based on test outcomes, implants are categorized as follows:

  • MR Safe: No known risks under any MRI conditions.

  • MR Conditional: Safe only under defined MRI conditions, which may include field strength, gradient specifications, RF coil types, and spatial positioning.

  • MR Unsafe: Known to pose risks and should not be used in MRI settings.

ASTM Standards We Apply

  • ASTM F2503: Standard practice for marking medical devices for MRI safety

This standard outlines the labeling system and requirements to indicate whether a medical device or material is safe or conditionally safe for use in the MRI environment.

  • ASTM F2052: Measurement of magnetic displacement force

This standard is used to measure the displacement force that acts on a medical device, implant, or product due to the static magnetic field of the MRI scanner. It evaluates whether the force represents a safety risk.

  • ASTM F2213: Measurement of magnetically induced torque

This standard assesses the torque induced on medical devices, implants, or products by the static magnetic field of the MRI scanner and determines whether this torque may pose a risk.

  • ASTM F2182: Evaluation of RF-induced heating near passive implants

This standard covers the measurement of radiofrequency (RF)-induced heating on or near passive implants during MRI. The results help determine if the implant causes excessive heating and establish safe MRI scanning conditions.

  • ASTM F2119: Assessment of MRI image artifacts from passive implants

This standard evaluates artifacts—such as geometric distortions and signal loss—caused by passive implants in MRI images. It uses key clinical sequences to quantify artifact size and assess the diagnostic impact.

At Pulsecraft Technology, we perform all MRI compatibility and safety tests in compliance with ASTM standards, including magnetic displacement, torque, RF-induced heating, and image artifact evaluations. These tests are carried out using state-of-the-art MRI scanners and certified measurement equipment at UMRAM, the National Magnetic Resonance Research Center at Bilkent University.

Reports

We interpret the results according to ASTM guidelines and determine whether your medical device or implant is MR Safe, MR Conditional, or MR Unsafe. If the device is conditionally safe, we issue a certificate specifying the exact MRI conditions under which it can be used safely. In addition, we provide a detailed test report summarizing all measurements and outcomes, available in English or Turkish depending on your preference.

The number and type of tests required may vary depending on the implant’s model, category, and variations. In some cases, repeated testing on identical samples may be advised to ensure result reliability. Please contact us to determine the most appropriate testing protocol for your device.

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