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    Device Humidity Testing Evaluation Method

    Testing the device's protective materials to prevent moisture penetration or ingress. (Food and Drug Administration)




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    A device that malfunctions as the result of exposure to undesirable levels of humidity
    Testing the device for its affect or impact on the blood or its components.
    The device affects or impacts the blood or its components. (See ISO 10993)
    A problem that results from improper sequencing or activation of electronic components.
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    User handling not in accordance with specification.

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