The New ISO/IEC Standard for Automated ECG Interpretation

Updates to industry consensus standards for ECG equipment is a work-in-progress by the ISO/IEC Joint Work Group 22. This work will result in an overhaul of existing that apply electromedical and new single international industry, namely 80601-2-86. The standard be entitled “80601, Part 2-86: Particular requirements basic safety essential performance electrocardiographs, including diagnostic equipment, monitoring ambulatory electrodes, cables, leadwires”. paper provide high-level overview progress and, particular, describe impact it have on testing methods computerized interpretation algorithms. conclusion this manufacturers should continue working with clinical experts make clinically meaningful improvements automated interpretation, validation analysis algorithms disclosed guide appropriate use. More cooperation needed between regulatory agencies develop data sets can made available use algorithm evaluation.