MRI Safety Testing

Elevate your medical device testing to global standards

Elevate your medical device testing to global standards

The Importance of MRI Safety

MRI SafetyMedical devices, including medical implants, in a magnetic resonance imaging (MRI) environment pose risks, such as electromagnetic interactions and radiofrequency heating, to patients.

The MRI safety testing of medical devices is necessary to ensure the patient's safety, implant performance, and compliance with the regulations. Our state-of-the-art laboratories, highly skilled professionals, comprehensive international accreditations, and membership in the CB scheme facilitate your market approval in addition to the medical device certification.

Medical Device Testing for the MRI Environment

TÜV SÜD is one of the leading providers offering a variety of medical device testing services. Our facility in New Brighton, MN is ISO/IEC 17025:2017 accredited by the American Association for Laboratory Accreditation (A2LA) and can test for various ASTM standards.

Non-active medical implants - MRI Safety

mri safety

MRI Safety Testing and Certification Services

TÜV SÜD offers a wide range of services and tests to assess medical devices' safety in the MRI environment. 

Our Services Include:

  • MRI Safety Product Testing and Labeling:
    • Radiofrequency Interactions
      • Induced heating
      • Unintended stimulation
      • Device malfunctionMRI Safety
    • Gradient Interaction
      • Induced heating
      • Unintended stimulation
      • Induced vibration
      • Device malfunction
    • Static Interaction
      • Induced Force
      • Induced Torque
      • Device malfunction
    • Image Artifacts
    • Labeling
  • Testing Against the Requirements of the Following Standards
    • ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging.
    • ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
    • ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
    • ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
    • ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
  • Our Highly Skilled Experts Also Offer
    • MRI safety testing service for products in the design and development phase
    • Testing services throughout the entire product development process
    • Training

    If you are unable to find the service you require, contact us. Our laboratory offers a wide range of services to meet your needs.

 

 

How TÜV SÜD can help you

Key Market Approvals from a Single Partner

We are the world's leading Notified Body in medical device conformity assessment with a high focus on implantable devices. We can issue CB reports and CB certificates accepted in more than 40 countries.

Take Advantage of our “Legacy Device Booster Program”

Solution to label your existing product portfolio for MR Safety and expand life cycle.

Marketing Advantage and a Path to a Competitive MR-Labeling

Our advanced technical knowledge in device testing and regulatory compliance is supported by our global network of healthcare and medical device testing experts, qualified engineers, and medical doctors. Our experts evaluate your medical devices and the MR-labeling to ensure patient safety.

Active Involvement in Standards Development and Implementation

TÜV SÜD actively participates in key standards committees and is involved in standards developments and implementation of medical devices in the EU, U.S., and Asia-Pacific.

Next Steps

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