Clinical Validation

Why Validation is Important

It’s not enough to just say we’re accurate. We have to prove it. That’s why we make sure every model of our OMRON blood pressure monitors meets the highest standards of precision and reliability.

Each model is tested according to the protocols of three major standards developing organizations: The Association for the Advancement of Medical Instruments (AAMI), the European Society of Hypertension (ESH) and the British Hypertension Society (BHS).

These validations offer peace of mind not just for our customers, but for physicians as well, who can rest assured that their patients are monitoring their health with the same reliability as the medical devices used in their examination rooms.

Model Number Reference Number ESH-IP
European Society of Hypertension International Protocol		 AAMI
Association for the Advancement of Medical Instrumentation		 BSH
British Hypertension Society		 Validation
BP4350 HEM-6232T-Z X X 22
BP5100 HEM-7122-Z X X 6, 21
BP5250 HEM-7151T-Z X X 8, 9, 21
BP5350 HEM-7341T-Z X X 6, 21
BP5450 HEM-7343T-Z X X 6, 21
BP6100 HEM-6180-Z X X 22
BP629 HEM-6200-Z X X 1
BP629N HEM-6130-Z X X 3
BP6350 HEM-6231T-Z X X 22
BP652 HEM-6052-CA; HEM-6052-Z; HEM-6052-ZCD6 X X 2
BP652N HEM-6300-Z X X 3
BP653 HEM-6320T-Z X X 3
BP654 HEM-6320T-Z X X 3
BP7000 HEM-7600T-Z X 19
BP710 HEM-7113-Z; HEM-7113-CAN; HEM-7114-SW X X 1, 5
BP7100 HEM-7121-Z2 X X 6, 21
BP7100CAN HEM-7121-CA X X 6, 21
BP710CANN HEM-7121-CA X 6
BP710N HEM-7121-Z X 6
BP7200 HEM-7150-Z X X 6, 21
BP7250 HEM-7150T-Z X X 6, 21
BP7250CAN HEM-7150T-CA X X 6, 21
BP7350 HEM-7340T-Z X X 8, 9, 21
BP7350CAN HEM-7340T-CA X X 8, 9, 21
BP742 HEM-7200-Z; HEM-7200-Z(V); HEM-7200-CA X X 1
BP742CANN HEM-7131-CA X 6
BP742N HEM-7131-Z X 6
BP7450 HEM-7342T-Z X X 8, 9, 21
BP7450CAN HEM-7342T-CA X X 8, 9, 21
BP760 HEM-7220-Z X X 7
BP760N HEM-7320-Z X 8
BP761 HEM-7320T-Z X 8, 9
BP761N HEM-7320T-Z X 8, 9
BP761CAN HEM-7320T-CA X 8, 10, 11
BP761CANN HEM-7320T-CA X 8, 10, 11
BP765 HEM-7311-ZSA X 6, 12, 13
BP765CAN HEM-7311-CACS X 6
BP785 HEM-7222-Z X X  7
BP785N HEM-7321-Z X 8
BP786 HEM-7321T-Z X 8
BP786N HEM-7321T-Z X 8
BP786CAN HEM-7321T-CA X 8
BP786CANN HEM-7321T-CA X 8
BP7900 HEM-7530T-Z X X 6, 21
BP791IT HEM-7222-ITZ X X 7
BP792IT HEM-7080-Z(V); HEM-7081-ITZ; HEM-7080-ITZ2; HEM-7080-ITCAN X X X 14
BP8000-M HEM-6410T-ZM X 20
HBP-1300 HBP-1300-Z X 15
HEM-705CPN HEM-759P-Z; HEM-759P-CAN; HEM-759P-B(C) X X X 16
HEM-712CLCN2 HEM-7051-ZL X 17
HEM-907XL HEM-907-Z2 X X X 18
  1. Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. Validation of four automatic devices for selfmeasurement of blood pressure according to the international protocol of the European Society of Hypertension. Vascular Health and Risk Management 2011:7;709-717.
  2. Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the OMRON M6 (HEM-7001-E) and the OMRON R7 (HEM 637-IT). Blood Press Monit 2006;11:165-171.
  3. Takahashi H, Yoshika M, Yokoi T. Validation of OMRON RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2013;9:265-72.
  4. Takahashi H. Validation of the OMRON M6W upper arm blood pressure monitor, in oscillometry mode, for self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2012 Mar 01. 4 p.
  5. Takahashi H. Validation of the OMRON M3W upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2012 Mar 01. 4 p.
  6. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON M6 AC (HEM-7322-E) upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 Jan 22. 4 p.
  7. Topouchian J, Agnoletti D, Blacher J, Youssef A, Chahine MN, Ibanez I, Assemani N, Asmar R. Validation of four devices: OMRON M6 Comfort, OMRON HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol. Vasc Health Risk Manag. 2014 Jan 16;10:33-44.
  8. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON M6 Comfort (HEM-7321-E) upper arm blood pressure monitor, in oscillometry mode, for clinic use and self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 Jan 22. 4 p.
  9. Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vascular Health and Risk Management 2007;3(4):389-400.
  10. El Assad M, Topouchian J, Asmar R. Evaluation of two devices for self-measurement of blood pressure according to the international protocol: the OMRON M5-I and the OMRON 705IT. Blood Press Monit 2003;8(3):127-133.
  11. Stergiou GS, Yiannes NG, Rarra VC. Validation of the OMRON 705 IT oscillometric device for home blood pressure measurement in children and adolescents: The Arsakion School Study. Blood Pressure Monitoring 2006;11:229-234.
  12. White WB, Anwar YA. Evaluation of the overall efficacy of the OMRON office digital blood pressure HEM-907 monitor in adults. Blood Press Monit 2001;6:107-110.
  13. Omboni S, Riva I, Giglio I, Caldara G, Groppelli A, Parati G. Validation of the OMRON M5-I, R5-I and HEM-907 automated blood pressure monitors in elderly individuals according to the International Protocol of the European Society of Hypertension. Blood Pressure Monitoring 2007;12:233-242.
  14. Coleman A, Steel S, Freeman P, de Greeff A, Shennan A. Validation of the OMRON M7 (HEM-780-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit 2008;13:49-54.
  15. Takahashi H, Yokoi T, Yoshika M. Validation of the OMRON HBP-1300 upper arm blood pressure monitor, in oscillometry mode, for clinic use in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dablEducational Trust; 2014 May 22. 4 p.
  16. Coleman A, Freeman P, Steel S, Shennan A. Validation of the OMRON 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit 2006;11:27-32.
  17. Asmar R, Khabouth J, Topouchian J, El Feghali R, Mattar J. Validation of three automatic devices for self-measurement of blood pressure according to the International Protocol: The OMRON M3 Intellisense (HEM-7051-E), the OMRON M2 Compact (HEM 7102-E), and the OMRON R3-I Plus (HEM 6022-E). Blood Press Monit 2010;15(1):49-54.
  18. El Assaad MA, Topouchian JA, Darne BM, Asmar RG. Validation of the OMRON HEM-907 device for blood pressure measurement. Blood Press Monit 2002;7:237-241.
  19. Takahashi H. Validation of the OMRON EVOLV (HEM-7600T-E) upper arm blood pressure monitor, in oscillometry mode, for self measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010 [Internet]. Dublin: dabl Educational Trust; 2016 November 28.
  20. Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ ISO81060-2:2013 guidelines: OMRON HEM-6410T-ZM and HEM-6410T-ZL. J Clin Hypertens. 2019;00:1–6.
  21. 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.
  22. Saito K, Hishiki Y, Takahashi H.　Validation of two automatic devices, OMRON HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010.　Vasc Health Risk Manag. 2019 Mar 6;15:47-55.