Device Humidity Problem Evaluation Result

A device that malfunctions as the result of exposure to undesirable levels of humidity (Food and Drug Administration)

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Device Hematologic Testing Evaluation Method

Testing the device for its affect or impact on the blood or its components.

Device Hematologic Problem Evaluation Result

The device affects or impacts the blood or its components. (See ISO 10993)

Device Hardware Timing Problem Evaluation Result

A problem that results from improper sequencing or activation of electronic components.

Device Hardness Testing Evaluation Method

Testing the device's ability to resist deformation. Hardness is the property of a material that enables it to resist plastic deformation, usually…

Device Handling Issue Medical Device Problem

User handling not in accordance with specification.

Device Handling Code

A coded value specifying special handling requirements for the device. EXAMPLE(S): keep at room temperature, store upright.