Protocol | Year published | Sample size required (No. of paired readings) | Criteria indicating a valid device |
---|---|---|---|
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. |