Validation of the BTL ambulatory blood pressure monitoring NG ambulatory blood pressure monitoring device according to the Universal Standard International Organization for Standardization 81060-2:2018

OBJECTIVE: The aim of this study was to validate the BTL ambulatory blood pressure monitoring NG ambulatory blood pressure (BP) monitoring device in a general population, including children aged 4-12 years, according to the International Organization for Standardization 81060-2:2018 standard with amendments A1:2020 and A2:2024. METHODS: The study included both clinical and ambulatory validation. In the clinical part, 85 participants (50 adults and 35 children) underwent same-arm sequential measurements with alternating test device and reference readings. The ambulatory part involved 35 adults tested using a dynamic protocol on a bicycle ergometer with at least a 15% heart rate increase. All procedures strictly followed standard requirements, including arm circumference and BP distributions. RESULTS: The device met all validation criteria defined by the standard. In clinical testing, mean differences were -0.52 mmHg systolic and -0.39 mmHg diastolic, with standard deviations of 4.44 and 4.17 mmHg. All cuff subgroups also met criterion 1, and criterion 2 was fulfilled with standard deviations of 3.80 mmHg systolic and 3.35 mmHg diastolic, including the children subgroup. In the ambulatory validation, mean differences were -0.40 mmHg systolic and -0.50 mmHg diastolic, with standard deviations of 5.88 and 5.05 mmHg. CONCLUSION: To our knowledge, this is the first published validation of an ambulatory BP monitoring device that fully followed the unified 81060-2:2018 standard, including amendments A1:2020 and A2:2024. The device fulfilled all clinical and ambulatory validation criteria across all required distributions and age groups, including children.