Parameter | Recommendation |
---|---|
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) |