MIR Safety Testing

Medical 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 implantable medical devices is necessary to ensure the patient's safety, implant performance, and compliance with the regulations.

STEMart performs physical MRI testing for magnetically induced displacement force, magnetically induced torque, MR image artifact, and RF-induced heating on implant device (both active and non-active) to help manufacturer evaluate their device for safety in the MRI environment. We also provide the necessary information for MRI safety labeling and supporting scientific rationale that is reported in the instructions for use (IFU) of your device.

Applicable Standards

• ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
• ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Test Capabilities

• Gradient interaction
• Induced heating
• Induced vibration
• Unintended stimulation
• Device malfunction
• Radiofrequency Interactions
• Induced heating
• Unintended stimulation
• Device malfunction
• Magnetic Interaction
• Induced Force
• Induced Torque
• Device malfunction
• MR Image Artifacts
• Marking medical devices in the MR environment

STEMart provides a full range of testing services to help manufacturers ensure the safe use of implantable medical device in an MRI environment. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.