Updates to IEC/AAMI ECG standards, a new hybrid standard

Abstract

The current set of IEC particular standards that pertain to electrocardiograph (ECG) devices, namely, 60601-2-25, 60601-2-27, and 60601-2-47, which define requirements and testing for the essential performance and basic safety of diagnostic ECG, ECG monitoring and ambulatory ECG systems, respectively. These standards have been harmonized with the corresponding AAMI standards, namely EC11, EC13 and EC38. Together these standards have been in existence for decades and have evolved separately even though the technology used in these three clinical applications is very similar. A work proposal was initiated in the ISO/IEC Joint Work Group 22 (JWG22), which over sees the revision of these standards, to update the standards by creating a single new hybrid standard. The goal of this work is a joint endeavor between ISO and IEC to combine the three separate particular standards that cover ECG device and to harmonize the similar requirements that are common across all three types of devices into one set of general requirements. The requirements that separate specific to meeting the intended use and essential performance for each of the 3 types of devices (diagnostic, patient monitoring, and ambulatory ECG recording) will continue to remain as separate requirements.Furthermore, manufactures of ECG devices have also been required to meet standards for disposable electrodes (AAMI EC12), ECG cables and leadwires (AAMI EC53), and arrhythmia analysis performance reporting (AAMI EC57). In addition to the primary goal, a secondary goal for the JW22 work is to also incorporate these three AAMI standards into the ECG hybrid standard. This paper describes the work being done and highlights key updates, and explains the rationale for approaches and changes being made. The Joint Work Group is currently in the process of updating the committee draft of the new hybrid standard before requesting comments from National Standard Committees participating in JWG22.