Validating the accuracy of the YuWell YE680B automated upper-arm blood pressure monitor in pediatric and adult populations according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (ISO 81060-2:2018/Amd.1:2020/Amd.2:2024)

Accurate blood pressure (BP) measurement is essential for hypertension management. Automated oscillometric BP monitors must be validated according to international standards before clinical and home use. This study aimed to evaluate the accuracy of the YuWell YE680B automated upper-arm BP monitor in accordance with the ISO 81060-2:2018 Universal Standard and its amendments, Amd.1:2020 and Amd.2:2024. A validation study was conducted using the same-arm sequential measurement method in a mixed population of adults and children aged greater than or equal to 3 years. Reference BP measurements were obtained by two trained observers using a calibrated mercury sphygmomanometer and a dual-head stethoscope. Device accuracy was assessed according to ISO criteria 1 and 2, and agreement was evaluated using Bland-Altman analysis. A total of 100 participants contributed to 300 valid paired measurements. The mean difference (test - reference) was -0.3 ± 6.77 mmHg for SBP and 0.4 ± 6.08 mmHg for DBP, fulfilling the requirements of ISO criterion 1. The SD of the participant-level mean differences was 5.81 mmHg for SBP and 5.32 mmHg for DBP, meeting the thresholds of ISO criterion 2. Bland-Altman analysis demonstrated good agreement across the measured BP range, with differences evenly distributed across the supported arm circumference range (17-52 cm). The YuWell YE680B automated upper-arm BP monitor met the accuracy requirements of ISO 81060-2:2018/Amd.1:2020/Amd.2:2024 in a mixed population of adults and children aged greater than or equal to 3 years. These findings support its use for BP measurement in clinical and home settings.