Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
BP | Stride BP | Self-measurement for adults (Previous) | Equivalence claim without published evidence |
Legend: B BIHS Derivative, D DET Equivalence, J JHS Implied Equivalence, P Stride Equivalence, Y Internal declaration, Z Almost Certain
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Omron BP765 (HEM-7311-ZSA)
Takahashi H, Yoshika M, Yokoi T. Validation of two automatic devices for the self-measurement of blood pressure according to the ANSI/AAMI/ISO81060-2:2009 guidelines: the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z). Vasc Health Risk Manag. 2015 Jan;9(11):49-53. doi: 10.2147/VHRM.S72438. PMID: 25657587.
81060-2:2009 - Pass General population
Omron HEM-7120
Zhang P, Li X, Fang Z, Lu Y, Cui J, Du X, Hu R. Smartphone application-supported validation of three automatic devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7120, Yuwell YE680A and Cofoe KF-65B. Blood Press Monit. 2021 Dec 1;26(6):435-440. Epub: 2021 May 13. doi: 10.1097/MBP.0000000000000547. PMID: 34001755.
ESH-IP:2010 - Pass General population
Omron HEM-7121
Posokhov IN, Praskurnichiy EA, Orlova OS, Sukhodolova EA, Lystseva AV. Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less. Blood Press Monit. Epub: 2024 Jul 2. doi: 10.1097/MBP.0000000000000715. PMID: 38958495.
81060-2:2019 - Fail Small Cuff Size
Omron HEM-7130 (JP)
Takahashi H, Yoshika M, Yokoi T. Validation of three automatic devices for the self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7130, HEM-7320F, and HEM-7500F. Blood Press Monit. 2015 Apr;20(2):92-7. doi: 10.1097/MBP.0000000000000096. PMID: 25462531.
ESH-IP:2010 - Pass General population
Omron HEM-9200T
Takahashi H, Saito K, Yakura N. Validation of Omron HEM-9200T, a home blood pressure monitoring device for the upper arm, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol. J Hum Hypertens. 2022 Apr;36(4):416-419. Epub: 2021 Apr 9. doi: 10.1038/s41371-021-00536-1. PMID: 33837291.
81060-2:2013 - Pass General population
Omron HEM-9700T
Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of an automatic device for the self-measurement of blood pressure in sitting and supine positions according to the ANSI/AAMI/ISO81060-2: 2013 guidelines: the Omron HEM-9700T. Blood Press Monit. 2019 Jun;24(3):146-150. Epub: 2019 Feb 14. doi: 10.1097/MBP.0000000000000368. PMID: 31026232. Available from: journals.lww.com.
81060-2:2013 - Pass Sitting position
81060-2:2013 - Pass Supine position