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    Device Handling Issue Medical Device Problem

    User handling not in accordance with specification. (Food and Drug Administration)




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    A coded value specifying special handling requirements for the device. EXAMPLE(S): keep at room temperature, store upright.
    Evaluating a device's characteristics that may affect the self healing ability of an organism.
    Device problems that result from the gradient induced fields generated during radiologic procedures e.g. magnetic resonance imaging.
    Testing the RF shield around the coils of an MRI device for its ability to provide effective screening against electrical (eddy) currents…
    Testing the device's ability to cause damage to genetic material. (e.g., leading to outgrowths -- malignant tumors).
    The device's ability to cause damage to genetic material (e.g., leading malignant tumors). (See ISO 10993)

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