Device Hematologic Problem Evaluation Result

The device affects or impacts the blood or its components. (See ISO 10993) (Food and Drug Administration)

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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.

Device Growth Factor Evaluation Method

Evaluating a device's characteristics that may affect the self healing ability of an organism.

Device Gradient Induced Field Problem Evaluation Result

Device problems that result from the gradient induced fields generated during radiologic procedures e.g. magnetic resonance imaging.