New standards for ECG equipment

Abstract

A new standard for electrocardiographic (ECG) medical equipment is currently in development by the ISO/IEC Joint Work Group 22 (JWG22) and is 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 new standard will replace the current set of IEC particular standards that pertain to ECG equipment, namely, 60601-2-25 (diagnostic electrocardiographs), 60601-2-27 (ECG patient monitors), and 60601-2-47 (Ambulatory ECG) and also incorporates AAMI standards EC12 (disposable electrodes), EC53 (ECG cables and leadwires), and EC57 (arrhythmia analysis performance reporting). This new ECG device standard will define basic safety and essential performance requirements and compliance testing methods for all types of ECG devices including both legacy types of ECG devices as well as new types of ECG devices. In addition to the general requirements, specific requirements and testing methods will apply exclusively to devices claiming to be used as a diagnostic electrocardiograph, an ECG patient monitor, and or an ambulatory ECG device.The primary goal of the work to develop this new ECG standard is to combine and harmonize the content of the existing set of 6 ECG standards. In addition, because many of these standards are quite mature, this work provides an opportunity to update the content to align requirements and testing methods with changes in ECG technology as well as changes in the clinical use of ECG and the emergence of new types of ECG devices. The changes under consideration and the progress of this work by ISO/IEC JWG22 is reviewed. Specific updates are highlighted, including requirements for defibrillation recovery, changes for ECG filtering technology, and changes to address advancement in implanted pacing technology.