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Standards Development
The proposed document is addressed to manufacturers of magnetic resonance conditional implantable devices as well as manufacturers of magnetic resonance equipment and pertains to situations in which a patient with an magnetic resonance conditional implant undergoes an magnetic resonance examination.
The proposed document is intended to provide insights into technology and design choices commonly made in magnetic resonance equipment to ensure single fault safe operation, for mutual understanding in both manufacturer communities. This enables implant manufacturers to assess the risks for the examination of patients with implants in magnetic resonance equipment, including risks associated to single fault conditions, for which an “order of magnitude” estimate is given for the probability of occurrence. To enable the informative aspect of this document, the risk factors and the sequence of events that lead to a potentially dangerous situation are illustrated with selected examples.
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