Testing methods for MR safety and compatibility of medical devices.
Magnetic resonance (MR) safety and image compatibility are important issues when using medical devices in the environment of magnetic resonance imaging (MRI). MR testing of medical devices is required for device approval by the FDA and the EU notified bodies. Testing methods have been established for basic issues and were published as first ASTM International standards (formerly ASTM, the American Society of Testing and Materials). Moreover, individual safety concerns such as the safe functioning of the device and the MR system are a necessity for medical devices within an MR environment. Standardized tests increase the safety of the patient and support both the MR user and the device manufacturers. This paper describes the state of the art of MR testing methods and requirements for medical devices.
Schaefers
Gregor
G
MR Testing Laboratory, MR:comp GmbH, Gelsenkirchen, Germany. schaefers@mrcomp.com
Melzer
Andreas
A
D004869:Equipment Safety; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000295:instrumentation / Q000592:standards