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 by penetration. However, the term hardness may also refer to resistance to bending, scratching, abrasion or cutting. The usual method to achieve a hardness value is to measure the depth or area of an indentation left by an indenter of a specific shape, with a specific force applied for a specific time. (Food and Drug Administration)

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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.

Device Gradient Induced Field Effect Testing Evaluation Method

Testing the RF shield around the coils of an MRI device for its ability to provide effective screening against electrical (eddy) currents…

Device Genotoxic Testing Evaluation Method

Testing the device's ability to cause damage to genetic material. (e.g., leading to outgrowths -- malignant tumors).