Inspection and Testing of Electrocardiographs (ECG) Devices

Electrocardiographs are nowadays standard part of diagnostic procedure in healthcare systems since they have high significance in diagnosis of large number of diseases and disorders. Due to development of technology, especially electronics, these devices have been revolutionized since the first prototype was invented. Nowadays, these devices are able to perform automated diagnosis and measure multiple parameters at once. Multiple international standards define device life circle, from production to disposal. However, this sophistication of ECG devices raises numerous questions regarding safety and accuracy. This chapter describes basic principles of electrocardiography and ECG devices as well as gives overview of requirements in area of safety and performance inspection of these devices.