Abstract
The magnetic resonance (MR) environment presents unique safety hazards for implanted and accessory medical devices including unwanted device movement, tissue heating, device malfunction, and imaging artifacts. Ever increasing numbers of patients with implants and accessory devices undergo MRI exams, making MRI safety an important goal for all. This paper provides an overview of the current status of standards related to the testing and labeling of medical devices in the MR environment. These standards represent the efforts and ongoing collaborations between regulatory bodies, device manufacturers, scientists, and the medical community to assure the safety of patients and medical personnel in the MR environment. This paper discusses current and emerging challenges to MRI safety evaluation that present opportunities for future standards development.
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