Device Genotoxic Problem Evaluation Result

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

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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.

Device Fracture Problem Evaluation Result

Device problems caused by the separation of a component, object, or material into two or more pieces including shear.

Device Foreign Material Contamination Evaluation Result

The undesirable presence of any substance that does not belong either on the device or in an organism and may lead to…

Device Fluid Pressure Testing Evaluation Method

Testing the fluid pressure (pressure at some point within a fluid e.g. water or air) within a device.