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Validation of the hanvon KSY8600 blood pressure monitor in the general population based on ISO 81060-2:2018 + AMD1:2020 protocol

Journal of Human Hypertension (2026)Cite this article

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Abstract

This study evaluated the accuracy of the Hanvon KSY8600 blood pressure monitor in adult populations in accordance with the AAMI/ESH/ISO (ISO 81060-2:2018) and AMD 1:2020 standards. 90 people were recruited as research participants, among which 88 eligible participants were chosen and analyzed according to the research plan. The average age of these participants was 51.3 ± 17.35 years old, with an average arm circumference of 28.1 ± 3.41 cm, and with females accounting for 60.2%. The test results showed that the mean differences (standard deviations) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) displayed on the blood pressure monitor were -0.4 mmHg (2.09 mmHg) and −0.3 mmHg (1.86 mmHg) respectively, meeting the requirements of Criterion 1 (≤ ± 5 mmHg (8 mmHg)). Additionally, the average standard deviations of the participants’ SBP and DBP were 0.91 mmHg and 0.90 mmHg respectively. According to Table 1 of Criterion 2, the mean values of SBP and DBP were −0.4 mmHg and −0.3 mmHg respectively, with maximum allowable standard deviations of SBP and DBP of ≤6.93 and ≤6.95 mmHg respectively, meeting the requirements of Criterion 2. It was thus proved that the blood pressure monitor complies with ISO 81060-2:2018 + AMD1:2020, and is recommended for clinical and home blood pressure measurement for adults.

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Fig. 1: Appearance of the Hanvon KSY8600 blood pressure (BP) monitor.
Fig. 2: Distribution of blood pressure differences and arm circumference correlation for the KSY8600 device.

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Data availability

Analyses and generated datasets that support the current study are not available publicly. The datasets are available from the corresponding author on reasonable request.

References

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Acknowledgements

This study was funded by Beijing Hanvon Health Technology Co., Ltd.

Funding

This study was funded by Beijing Hanvon Health Technology Co., Ltd., the manufacturer of the Hanvon KSY8600 device. The sponsor had no role in the study design, data analysis, interpretation, or manuscript preparation.

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Authors and Affiliations

  1. Department of Cardiology, Beijing Geriatric Hospital, Beijing, 100095, Beijing, China

    Jian Wang & Chongjie Chen

  2. Institute of Automation, Chinese Academy of Sciences, Beijing, 100080, Beijing, China

    Yingjian Liu

Authors
  1. Jian Wang
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  2. Yingjian Liu
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  3. Chongjie Chen
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Contributions

JW: Conceptualization, Methodology, Investigation, Writing – Original Draft, Writing – Review & Editing, Supervision, Project Administration. YL: Conceptualization, Resources. CC: Investigation, Formal Analysis, Data Curation.

Corresponding author

Correspondence to Jian Wang.

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The authors declare no competing interests.

Ethical approval

The study was approved by the Ethics Committee of the Beijing Geriatric Hospital, and all participants provided written informed consent.

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Wang, J., Liu, Y. & Chen, C. Validation of the hanvon KSY8600 blood pressure monitor in the general population based on ISO 81060-2:2018 + AMD1:2020 protocol. J Hum Hypertens (2026). https://doi.org/10.1038/s41371-026-01111-2

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