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

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.
Source: Journal of Electrocardiology - Category: Cardiology Authors: Source Type: research