Table 2.

Key aspects of the AAMI/ESH/ISO universal validation standard14

Aspect	Requirement
Efficacy measure	Threshold for BP measurement accuracy acceptance at estimated probability of tolerable error (≤ 10 mm Hg) ≥85%.
Sample size	≥ 85 participants
General/special populations	A general population study includes participants > 12 years. Special populations: age < 3 years; pregnancy; arm > 42 cm; atrial fibrillation; others may be added. Special population studies include ≥ 35 participants (after successful general population study). Pregnancy: N = 45 (15 normotensive, 15 gestational hypertension, 15 preeclampsia). Korotkoff K5 for reference diastolic BP: Children: N = 35 aged 3‐12 years can be included and analyzed together with 50 older participants. Results also reported separately for children (not a pass/fail criterion). Korotkoff K5 for reference diastolic BP.
Cuff sizes	There is a minimum number of participants per cuff depending on number of test device cuffs. Requirements for arm circumference distribution according to range of use of the test device.
Reference BP	Mercury sphygmomanometers or accurate non‐mercury devices.
Data collection	Same‐arm sequential BP measurement is preferred.
Pass criteria	Average BP difference and SD criteria 1 and 2 of ANSI/AAMI/ISO. Absolute BP differences ≤ 5, 10, 15 mm Hg and scatterplots to be presented.