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