Clinical studies and validation of blood pressure monitors

Why validation is necessary?
The European Union and international organisations of specialists in hypertension have recommended that all devices for measuring blood pressure for clinical use or self control
should be independently validated for accuracy according to standard protocols. These standardized validation protocols define requirements for the accuracy of blood pressure
measurement devices and are taken as basis for recommendation of devices.

Which validation protocols do exist?
The Association for the Advancement of Medical Instrumentation (AAMI) published a standard for electronic aneroid sphygmomanometers in 1987 that included a protocol for
evaluating the accuracy of devices, this being followed in 1990 by the protocol of the British Hypertension Society (BHS). The BHS protocol was revised in 1993. It covers a wide range of blood pressure and sets a minimum standard to be achieved for device recommendation. The standard protocol released by the European Society of Hypertension (ESH) added specific requirements for intra-patient accuracy that had to be fulfilled for clinical recommendation.

The EN 1060-Part IV is a further recognized standard protocol which makes similar demands on accuracy like the quality seal. This highly qualified accredited award is approved by the German Hypertension League. Basis of clinical proof is the DIN EN 540 which is expanded by further requirements like selection of observer and evaluation of results.
The protocols have a common objective, namely the standardization of validation procedures to establish minimum standards of accuracy and performance, and to facilitate the comparison of one device with another.

Device EN 1060- Part IV German
Quality Seal

BHS

ESH AAMI
Tensoval duo control passed passed passed passed passed
Tensoval comfort passed passed not tested not tested not tested
Tensoval mobil passed passed passed not tested not tested