Accuracy of the Withings BPM Pro 2 (WPM07) Device for Self-Blood Pressure Measurements in the General Populations According to the International Organization for Standardization Universal Standard (ISO 81060-2:2018/AMD 2:2024) Protocol

Background: The accuracy of blood pressure (BP) measurements performed by electronic devices is crucial in clinical practice. International professional societies emphasize the need for rigorous, standardized validation of electronic BP measuring devices to ensure their accuracy and reliability. Objective: This study evaluated the accuracy of the Withings BPM Pro2 (WPM07) upper‑arm oscillometric BP monitor in the adult general population using the ISO 81060‑2:2018/AMD 2:2024 Universal Standard. Methods: Following the ISO same‑arm sequential measurement protocol, 89 eligible pre-selected participants underwent paired test‑device and mercury reference auscultatory measurements. Nine BP measurements were performed on each participant, four with the tested device and five with the auscultatory method. The accuracy of BP measurements was assessed based on the difference between simultaneous measurements taken by two observers and those displayed by the tested device using ISO Criterion 1 (mean and standard deviation of test-reference differences) and Criterion 2 (within‑subject variability of averaged difference values). Results: Eighty-nine participants underwent the BP measurements protocol, data from 87 were analyzed after excluding 2 participants due to excessive BP variability. Inter‑observer agreement for reference measurements was 0.64 ± 2.14 mmHg for systolic BP (SBP) and 0.39 ± 1.98 mmHg for diastolic BP (DBP). ISO criterion 1 was met with mean test-reference differences of 1.0 ± 4.9 mmHg (SBP) and 0.6 ± 4.1 mmHg (DBP) below ISO requirements (≤ 5±8 mmHg). ISO criterion 2 was also satisfied, with within‑subject standard deviations of 3.50 mmHg (SBP) and 3.01 mmHg (DBP), well below the ISO thresholds (≤6.87/6.91 mmHg). Conclusion: The BPM Pro2 (WPM07) fulfills the ISO 81060‑2:2018/AMD 2:2024 accuracy requirements and is suitable for reliable home BP self‑measurement in adults.