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ANSI/AAMI/ISO 81060-2:2019
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Specifies the requirements and methods for the clinical investigation of medical electrical equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing cuff. This document 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 document 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 and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).
Association for the Advancement of Medical Instrumentation [aami]