Inspection and Testing of Electrocardiographs (ECG) Devices

Due to its considerable importance in the diagnosis of a wide range of diseases and disorders, electrocardiographs (ECG devices) are currently a routine component of diagnostic procedures in healthcare systems. Since the creation of the initial prototype, these devices have undergone evolutionary changes due to advancements in technology, particularly electronics. These devices can now measure several factors simultaneously and do automatic diagnostics. The entire life cycle of a medical device of this type, from creation to disposal, is defined by numerous international standards and regulations. Yet, because of their current level of sophistication, ongoing legal framework changes their accuracy and safety during usage is largely considered. In addition to providing an overview of the criteria in the area of safety and performance inspection of these devices, this chapter discusses the fundamental concepts of electrocardiography and ECG devices. Lastly, a novel method for safety and performance inspection during usage of ECG devices based on their metrological characteristics is introduced.