Device Gradient Induced Field Problem Evaluation Result

Device problems that result from the gradient induced fields generated during radiologic procedures e.g. magnetic resonance imaging. (Food and Drug Administration)

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Device Gradient Induced Field Effect Testing Evaluation Method

Testing the RF shield around the coils of an MRI device for its ability to provide effective screening against electrical (eddy) currents…

Device Genotoxic Testing Evaluation Method

Testing the device's ability to cause damage to genetic material. (e.g., leading to outgrowths -- malignant tumors).

Device Genotoxic Problem Evaluation Result

The device's ability to cause damage to genetic material (e.g., leading malignant tumors). (See ISO 10993)

Device Generator Malfunction

The device has a generator malfunction.

Device Friction Problem Evaluation Result

A device problem caused by its surface coming in contact with another surface or fluid.

Device Fracture Toughness Testing Evaluation Method

Testing the device's ability to resist local separation into two, or more, pieces under the action of stress.