TABLE 2.

Comparison of validation protocols for BP measuring devices in children.

	BHS revised (1993) (3)		ANSI/AAMI/ISO (2013) (7)		AAMI/ESH/ISO (2018) (8)
	After a successful study in general population		Device for children and adults or with pediatric mode:	Devices only for children:	Devices for both general population and children: (after a successful 85-subject study in general population)	Devices with a special pediatric mode: (after a successful 85-subject study in general population)	Devices only for children: (without previous study in general population)
Age range	0–5 years	5–15 years	3–12 years		3–12 years and ≥ 12 years	3–12 years	3–12 years
Sample	30 subjects	30 subjects	35 subjects	85 subjects	85 subjects	35 subjects	85 subjects
Age distribution	0–12 months: 15 subjects, 1–5 years: 15	Evenly distributed	Not specified		3–12 years: 35 subjects, > 12 years: 50	Not specified	Not specified
Sex distribution	≥10 each of sex	By chance	≥30% of each sex		≥30% of each sex
BP range distribution	SBP: 5/30 > mean + 1 SD for population DBP: 5/30 < mean—1 SD for population	SBP: 5/30 > mean + 1 SD for population 5/30 < mean—1 SD for population DBP: 4/30 > mean + 1 SD for population 5/30 < mean—1 SD for population	Not specified		As the total 85-subject study	Without BP distribution requirements
Arm circumference distribution	Not specified	5/30 > 70th centile for weight 5/30 < 30th centile for weight	Single cuff: 40% of subjects’ circumference within upper half of range; 40% within lower half; 20% of subjects’ circumference within upper quarter of range; 20% within lower quarter. N cuffs, test each in ≥ 1/(2 × n) subjects		Single cuff: 40% of subjects’ circumference within upper half of range; 40% within lower half; 20% of subjects’ circumference within upper quarter of range; 20% within lower quarter. N cuffs, test each in ≥ 1/(2 × n) subjects
Reference BP measurement device	Conventional mercury sphygmomanometry	Mercury sphygmomanometer, or non-mercury auscultatory device with max permissible error ± 1 mmHg	Mercury sphygmomanometer, or non-mercury auscultatory device with max permissible error ± 1 mmHg
Reference diastolic BP	K5	K4	K4
Pass criteria	Mean difference and SD for test-reference BP differences to be reported No pass threshold is provided	Criterion 1: mean ± SD for test-reference BP differences ≤ 5 ± 8 mmHg Criterion 2: intersubject SD of BP differences within threshold defined by the mean of criterion 1	Mean difference and SD of SBP and DBP should be reported separately for subgroups aged 3–12 and > 12 years Pass criteria: validation criteria 1 and 2 Criterion 1: mean ± SD for test-reference BP differences ≤ 5 ± 8 mmHg Criterion 2: intersubject SD of BP differences within threshold defined by the mean of criterion 1	Validation criterion 1	Validation criteria 1 and 2

BP: blood pressure, SBP: systolic blood pressure, DBP: diastolic blood pressure, SD: standard deviation.