Health / Medical Topics

    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 infection or fever. (Food and Drug Administration)




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    Testing the fluid pressure (pressure at some point within a fluid e.g. water or air) within a device.
    Testing the device to assess the volume of fluid moving per unit of time. This may also include filter testing.
    Testing the device's capability to withstand the progressive and localized structural damage that occurs when a material is subjected to cyclic…
    Device problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses. …
    A device problem related to the user not following the manufacturer's instructions.
    A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings. …

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