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MRI Safety for Implantable Cardiac Devices
 

Standards and Guidelines

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Industry Standards

  • ASTM F2052-02 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2182-02a Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging 
  • ASTM F2119-01 Standard Test Method for Evaluation of MR Image Artifacts From Passive Implants
  • F2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

 

Guidelines and Recommendations

  • CDRH Draft Document: "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems"
  • FDA Public Health Notification: MRI-Caused Injuries in Patients with Implanted Neurological Stimulators – May 10, 2005
  • Criteria for Risk Investigations of Magnetic Resonance Diagnostic Devices (PDF, 36 KB)

 

Last updated: 26 Feb 2013

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