Quality assurance in biosignal processing - procedures and recommendations for evaluation for electrocardiological analysis systems

Following a European R&D project for conformance testing, a pilot test centre for computer-assisted electrocardiography has been established at the Medical School Hannover, Germany. Since 1993, many manufacturers have contacted our test centre and provided new ECG devices (ECG amplifiers or computerized ECG systems) for testing. The layout of the test system is described as well as new testing tools, e.g. artificial calibration signals, annotated real ECGs and the test procedures. Testing results are presented for devices from nine manufacturers. Our experience from the tests performed (in part, jointly with the manufacturers) and from devices on the market proves that the new testing tools and the new procedures developed during the "Conformance Testing Services" (CTS) project are extremely valuable in promoting the accuracy of signal reproduction in electrocardiography and the measurements of computerized ECG systems