Table 1 Major blood pressure device validation protocols

BHS [48]

1990

85 (255)

Device graded from A to D. Grade A is the highest level of accuracy and requires that the percentage of readings with a difference between the device-under-test and the reference sphygmomanometer of ≤5, 10, and 15 mm Hg be 65, 85, and 95%, respectively.

ESH International Protocol [49]

2010

33 (99)

Pass requirements are split into 2 phases and are based on the number of measurements with differences between the device-under-test and reference sphygmomanometer of ≤5, 10, and 15 mm Hg. See protocol for details. This protocol is being phased out, to be replaced by a joint universal AAMI/ESH/ISO validation protocol requiring 85 subjects.

AAMI/ANSI/ISO [50]

2013

85 (255)

• Criterion 1: when analyzed as 255 paired determinations, the mean difference between the device-under-test and reference sphygmomanometer is < 5.0 mm Hg, and the SD of the difference is < 8.0 mm Hg.

• Criterion 2: when analyzed as 85 paired determinations, the SD of the difference between the device-under-test and reference sphygmomanometer is < 4.79 to 6.95 mm Hg (the actual threshold varies according to the mean difference observed. See protocol for details).

AAMI/ESH/ISO [51]

2018

85

• A device is considered acceptable if its estimated probability of a tolerable error (≤10 mmHg) is at least 85%.

• The mean BP difference (test versus reference) and its SD, criteria 1 and 2 of the ANSI/AAMI/ISO 81060–2, to be applied for systolic and diastolic BP.