This standard specifies the requirements and methods for the clinical validation of medical electrical equipment used for the intermittent non-invasive automatic estimation of the arterial blood pressure by utilizing a cuff. It is applicable to all sphygmomanometers that sense or display pulsations, flow, or sounds for the estimation, display, or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This standard covers sphygmomanometers intended for use in all patient populations (i.e. all age and weight ranges, and all conditions of use, e.g., ambulatory blood pressure monitoring, stress testing blood pressure monitoring). It is also applicable to the validation of electronically-controlled intermittent non-invasive blood pressure measurement medical electrical equipment, including blood pressure monitors for the home healthcare environment or self-measurement.
ANSI/AAMI/ISO 81060-2:2013 history
1970ANSI/AAMI/ISO 81060-2:2019 Non-invasive sphygmomanometers— Part 2: Clinical investigation of intermittent automated measurement type
2013ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical invastigation of automated measurement type