The Effect of Expanded Measurement Uncertainty on the Outcome of Blood Pressure Measurement Validation Protocol Based on the ISO81060-2:2018 Guideline - A Monte Carlo Simulation Approach

The most common hemodynamic measurement technologies are the classical auscultatoric sphygmomanometric method and numerous solutions for automated sphygmomanometry. The classical method is the reference for testing the automated solutions according to the ISO81060-2:2018 guideline. Both of the above mentioned blood pressure estimations are indirect measurement methods according to the approach of metrology. According to the ISO81060-2:2018 guideline, two indirect measurement and estimation methods are compared with each other without the theoretical and technical consideration of the possible effect of the measurement uncertainty on the results. Within this simulation study several components of the measurement uncertainty were implemented to test the reliability and confidence limit of the ISO guideline recommended process flow, experimental design and statistical analysis.