European Conformance Testing Services for computerized electrocardiography. New procedures and standards.
Performance requirements and national, as well as international, standards for computer-assisted electrocardiography are behind today's technology. Upgrading is urgently needed from a legal point of view, as well as from a technologic point of view. In Europe a new directive on medical devices requires that instruments with a measurement function have to provide the appropriate measurement accuracy and that manufacturers must specify its measurement accuracy. This study addresses the problem. A description for a new testing system for computer-assisted electrocardiography is given. Also, new tools, for example, the Conformance Testing Services database, and minimum performance requirements for testing computer-assisted electrocardiographs are described and discussed.
Zywietz
C
C
Medical School, Hannover, Germany.
Willems
J L
JL
D002138:Calibration; D003936:Diagnosis, Computer-Assisted / Q000592:standards*; D004562:Electrocardiography / Q000592:standards*; D006801:Humans; D011786:Quality Control; D012815:Signal Processing, Computer-Assisted