Nov 28, 2018
AAMI Newsletter (November 2018)
Standards Spotlight: 'Mega Standard' in the Works for Electrocardiographic Equipment
Six standards that cover electrocardiographic (ECG) equipment are undergoing revisions that will result in one consolidated, “mega” standard by late 2020. The International Electrotechnical Commission (IEC) standard under development, which AAMI plans to adopt as an American National Standards Institute (ANSI) standard, will be ANSI/AAMI/IEC 80601-2-86: Medical electrical equipment—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.