All assumptions relating to the diagnosis and management of hypertension are dependent on the accurate measurement of blood pressure.

The history of blood pressure measurement makes fascinating reading. For a general history of the beginnings and evolution of blood pressure measurement over the centuries, see references 1 to 5.

All decisions relating to the diagnosis and treatment of high blood pressure are dependent on accurate measurement. The first efforts to have blood pressure devices clinically validated independently was in 1982 [6] and, in 1989, it was proposed that a standardised protocol should be produced for the independent validation of blood pressure measuring devices [7]. In the late nineteen-eighties, the American National Standards Institute (ANSI), with the Association for the Advancement of Medical Instrumentation (AAMI), and the Deutsches Institut für Normung (DIN) published standards for blood pressure measuring devices and there have been several revisions since then (see Clinical Validation Protocols for Blood Pressure Monitors below). In 1990, the British Hypertension Society Protocol was published [8] and revised in 1993 [9]. This protocol was succeeded by the International Protocol of the European Society of Hypertension in 2002 [10] and the revised International Protocol published in 2010 [11] became the protocol used most widely in the world for evaluating blood pressure measuring devices.

The first universal protocol, called ISO 81060-2:2018 was published in December 2018 [12]. This extended the previous ISO 81060-2:2013 protocol [13] to include elements of the 2010 ESH protocol [11, 14, 15]. It was adopted by AAMI and ANSI in August 2019 [16] and by the EU and Great Britain in December 2019 [17] before becoming the official EU harmonised protocol on 25 March 2020 [18]. Therefore, this will be the harmonised protocol for blood pressure monitors that will be required for MDR compliance with EU 2017/745 regulations [19]. These regulations were implemented on 26 May 2021 [20].

In the light of EU MDR, the European Commission as also implemented regulations regarding instructions for medical devices being supplied in electronc form. [21]

National and international societies of hypertension publish guidelines on the management and drug treatment of hypertension but a need to publish guidelines devoted specifically to the measurement of blood pressure has been recognised and addressed by members of the Medaval’s Scientific Panel of experts over a number of years. [22-31]