AAMI/ISO 81060-2:2009 Historical

AAMI/ISO 81060-2 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. This standard is not applicable to the validation of non-automated sphygmomanometers as given in IEC/ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34. See more