Development of Test Methods for Disposable ECG Electrodes. Volume 1

摘要

This report describes the work done under FDA Contract 223-74-5253, Task Order No. 27, 'Development of Test Methods for Disposable ECG Electrodes.' A separate report covers related work performed under Contract FDA 223-77-5034, Task 1, to develop electrode adhesive test methods. The goal of this study was to develop test methods for electrical and adhesive properties of disposable ECG electrodes in support of a standard being prepared by the AAMI Subcommittee on Electrodes. Tests were to be developed for electrode impedance, offset, drift, bias current tolerance, and defibrillation overload recovery. The approach taken was, where possible, to develop simple bench tests appropriate for inclusion in the standard which would test for clinically important performance. This was done by making measurements on humans or animals using a broad range of commercially available disposable electrodes and then correlating these results with performance of bench tests.