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Device Hematologic Testing Evaluation Method
Testing the device for its affect or impact on the blood or its components. (Food and Drug Administration)
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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.
Testing the device's ability to resist deformation. Hardness is the property of a material that enables it to resist plastic deformation, usually…
User handling not in accordance with specification.
A coded value specifying special handling requirements for the device. EXAMPLE(S): keep at room temperature, store upright.
Evaluating a device's characteristics that may affect the self healing ability of an organism.