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Device Environmental Evaluation Method
Evaluating devices for responses to physical characteristics in their surroundings. (Food and Drug Administration)
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A device problem that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature.
Device problems related to the energy storage system (e.g. the rechargeable battery, charging system, or capacitor) and includes problems such as premature…
The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria).
Device problems that occur from its reaching the end of its useful life.
Testing the device for adequately controlled electromagnetic emissions.
Movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel.
