Table 3.
Standards | Reference device | Sample Size | Difference between standard and test device (mmHg) | Recommendation for clinical use | |||
---|---|---|---|---|---|---|---|
Mean | Standard deviation (SD) | ||||||
American National Standard: ANSI/AAMI/ISO 81060-2:2013 | Mercury sphygmomanometer | ≥ 85 | ≤ 5 | ≤ 8 | Yes | ||
British Hypertension Society (BHS) | Mercury sphygmomanometer | ≥ 85 | Grade | Absolute difference | |||
≤ 5 | ≤ 10 | ≤ 15 | |||||
A | 60% | 85% | 95% | Yes | |||
B | 50% | 75% | 90% | Yes | |||
C | 40% | 65% | 85% | No | |||
D | Worse than C | No | |||||
European Society of Hypertension International Protocol (ESH-IP) | Mercury sphygmomanometer | 33 | Grade | Absolute difference | |||
≤ 5 | ≤ 10 | ≤ 15 | |||||
1 | 73% | 87% | 96% | Yes | |||
2/3 ≤ 5 | 0/3 ≤ 5 | – | |||||
2 | ≥ 24% | ≤ 3% | Yes | ||||
3 | – | – | – | No | |||
IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices (IEEE Std 1708-2014) | All types of wearable BP measurement devices | 45 | Grade | Mean absolute difference (MAD) | |||
A | ≤ 5 | Yes | |||||
B | 5–6 | Yes | |||||
C | 6–7 | Yes | |||||
D | ≥ 7 | No |