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  • Devices designed primarily to measure, assess, simulate, or calibrate the performance and/or safety characteristics of medical devices and accessories; testers are usually dedicated equipment used to measure and/or evaluate one or more parameters of the device under test. Testers may include measuring instruments, electronic data processors, and/or recorders. Most testers are used during the periodical and postrepair evaluation and/or calibration of the electric, mechanical, or other physical characteristics (e.g., pressure, temperature) of medical devices; some testers are designed to simulate some physical characteristic of the human body (i.e., phantoms) or of the functioning of an organ or tissue (e.g., simulator of bioelectric signals).
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