Device Properties Domain

Definition 1

A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to device properties. (NCI Thesaurus)

Definition 2

A domain for the characteristics of the device that do not vary over the course of the study. (NCI Thesaurus/CDISC)

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Device Process Evaluation Method

Performing a review of the manufacturing and production processes and/or records for a specific device or lot that may have contributed to…

Device Problem

Medical device failure or malfunction associated with device functions, including any deviations from documented specifications, requirements, and intended uses.

Device Pressure Testing Evaluation Method

Testing the device's characteristics when subjected to high or low pressure conditions.

Device Power Source Testing Evaluation Method

Testing the power sources in a device e.g., battery, internal power supply to detect any malfunction.

Device Power Source Problem Evaluation Result

Problems that are related to the device that provides power.

Device Power Frequency Magnetic Field Testing Evaluation Method

Tests performed to verify a device's level of protection (immunity) against magnetic disturbances while operating.