Legend: J JHS Implied Equivalence, Y Internal declaration
Takahashi H, Saito K, Hishiki Y. Validation of Omron HEM-7600T, a wearable device for monitoring blood pressure, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2: 2013 protocol in the general population without arrhythmias. Blood Press Monit. Epub: 2021 Feb 8. doi: 10.1097/MBP.0000000000000520. PMID: 33577185.
81060-2:2013 - Pass General population
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 Evolv (HEM-7600T-E)
Topouchian J, Hakobyan Z, Asmar J, Gurgenian S, Zelveian P, Asmar R. Clinical accuracy of the Omron M3 Comfort® and the Omron Evolv® for self-blood pressure measurements in pregnancy and pre-eclampsia - validation according to the Universal Standard Protocol. Vasc Health Risk Manag. 2018 Aug 31;14:189-97. doi: 10.2147/VHRM.S165524. PMID: 30214220. Available from: PMC6124447. eCollection 2018.
81060-2:2013 - Pass Normotensive pregnancy, Hypertensive pregnancy and Pre-eclampsia (n=45) (Note: Only one set of ISO results provided.)
BHS:1993 - Pass (A/A) Normotensive pregnancy, Hypertensive pregnancy and Pre-eclampsia (n=45)
Validation under the "Universal Protocol" is claimed, though only a consensus document was written, at that time, as referenced. Analysis appears to be according to Criterion 1 of ISO 81060-2:2013 and to BHS 1993.
Takahashi H. Validation of Home Blood Pressure-monitoring Devices Omron EVOLV (HEM-7600T-E), HEM-9210T, and M3 Comfort (HEM-7134-E) According to European Society of Hypertension International Protocol (ESH-IP) Revision 2010. J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46. doi: 10.34363/jocp.49.1_37. Available from: www.jstage.jst.go.jp.
ESH-IP:2010 - Pass General population