Table 4 Universal protocol of validation

Efficacy measure

Threshold for BP measurement accuracy acceptance at estimated probability of tolerable error (≤ 10 mmHg, ≥ 85%)

Sample size and age

General population: ≥ 85 participants, aged > 12 years

Sex

 ≥ 30% male and ≥ 30% female

Reference BP

Mercury sphygmomanometers or non-mercury sphygmomanometers those fulfill requirement for accuracy (maximum permissible error shall be ± 1 mmHg)

Test requirements (number)

Each of reference and test device ≥ 255

BP ranges

SBP: ≤ 100 (≥ 5%), ≥ 160 (≥ 5%), ≥ 140 mmHg (≥ 20%)

DBP: ≥ 60 (≥ 5%), ≥ 100 (≥ 5%), ≥ 85 mmHg (≥ 20%)

Cuff size

• Cuff size-stratified subgroups with ≥ 2 cuffs

 → minimum of 22 subjects per cuff

•Set for the distribution of the participants arm circumference according to the specified range of use of the test device

Special populations

• Special populations: age < 3 years /pregnancy / arm circumference > 42 cm/atrial fibrillation, and others

• Special population studies include ≥ 35 participants after successful general population study

• Pregnancy: 45 subjects, Korotkoff K5 for reference DBP

• Children: 35 subjects, aged 3–12 years analyzed together with ≥ 50 years older subjects. Korotkoff K5 for reference DBP

Data collection

Same-arm sequential BP measurement

Pass criteria

• Criteria 1 (BP value): average BP difference ≤ 5 mmHg, standard error ≤ 8 mmHg

• Criteria 2: tolerable error

• Absolute BP differences ≤ 5, 10, 15 mmHg

• Scatterplots (standardized Bland–Altman plot)