Development of Test Methods and Draft Standard for Cardiac Monitors

摘要

This report contains an overview of the work done in developing various versions of a standard for cardiac monitors, heart rate meters and alarms. It includes a summary of tests performed on commercial monitors by UBTL to evaluate the test methods proposed in the standard. The methods used to develop the test waveforms for the standard are described in some detail. The review process conducted throughout the development of the various versions of the draft standard is also documented. A comprehensive mailing list of manufacturers and users of cardiac monitors, as well as the documentation of the test waveforms used in the standard were submitted as separate items.