Notable Similarities and Differences between AAMI/ANSI/ISO, IEEE, and BHS Standards
| | AAMI/ANSI/ISO | IEEE Standard (Amendment) | BHS |
| Subject Level Split Procedure | - Reference Cuff (Auscultation): 3 pairs of measurements for each subject
- Arterial Line: mean SBP and DBP over a 30 s period
| - Reference Cuff (Auscultation): 3 pairs of measurements for each subject
- Arterial Line: mean of all beats over a 20 s period
| - Reference Cuff (Auscultation): 5 phases based on deflation protocols and readings from two reference devices, including a device reliability test protocol for one month of use.
- Arterial Line: not recommended
|
| Personalization Procedure (Test with BP change from calibration point) | Not specified | SBP changes:- 13.6% with -30 to -15mmHg change
- 34.1% with -15 to 0mmHg change
- 34.1% with 0 to 15mmHg change
- 13.6% with 15 to 30mmHg change
DBP changes:- 13.6% with -20 to -10mmHg change
- 34.1% with -10 to 0mmHg change
- 34.1% with 0 to 10mmHg change
- 13.6% with 10 to 20mmHg change
| Not specified |
| Number of Subjects Required | 85 | - Phase 1: 20
- Phase 2: 65
| 85 | | Demographics (Adults/General Population) | - Age: ≥12 years old
- Sex: ≥30% males and ≥30% females
- SBP: ≥5% with ≤100 mm Hg, ≥5% with ≥160 mmHg, ≥20% with ≥140 mmHg
- DBP: ≥5% with ≤60 mmHg, ≥5% with ≥100 mmHg, ≥20% with ≥85 mmHg
| - Age: all subjects between 18 and 65 years old
- Sex: equal number of male and female subjects (≥22 each)
- SBP and DBP: equal distribution of
- Healthy (SBP<120mmHg, DBP<80mmHg)
- Prehypertension (120≤SBP<139, 80≤DBP<90)
- Stage 1 Hypertension (140≤SBP<160, 90≤SBP<100)
- Stage 2 Hypertension (SBP≥160, DBP≥100)
- Age: distribution by chance
- Sex: distribution by chance
- SBP: SBP<90mmHg (N=8), 90≤SBP<130mmHg (N=20), 130≤SBP<160mmHg (N=20), 160≤SBP<180mmHg (N=20), SBP>180mmHg (N=8)
- DBP: DBP<60mmHg (N=8), 60≤DBP<80mmHg (N=20), 80≤DBP<100mmHg (N=20), 100≤DBP<110mmHg (N=20), DBP>110mmHg (N=8)
| | Evaluation Metric | abs(Mean Difference) ± Standard Deviation | Mean Absolute Difference | Percentage of Absolute Differences binned by ≤5, ≤10, and ≤15mmHg in low (SBP<130 and DBP<80mmHg), medium (130≤SBP<160 and 80≤DBP<100), and high (SBP>160 and DBP>100) BP ranges | | Evaluation Criteria | Accept/Reject based on criteria:- Criterion 1: The differences in individual paired determinations of the device under investigation and the mean observer references should have a mean difference of ≤5mmHg and a standard deviation of ≤8mmHg.
- Criterion 2: The maximum permissible standard deviation of the difference between averaged readings from the device under investigation for each subject and observer references should be less than a particular value specified in ANSI/AAMI/ISO 81060-2:2019 Section 5.2.4.1.2. For instance, a mean difference of 0mmHg should have a standard deviation value of <6.95mmHg.
| Grading:- A: MAE≤5
- B: 5<MAE≤6
- C: 6<MAE≤7
- D: MAE≥7
| Cumulative percentage of readings:- ≤5mmHg: A (60%), B (50%), C (40%)
- ≤10mmHg: A (85%), B (75%), C (65%)
- ≤15mmHg: A (95%), B (90%), C (85%)
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Relationship between Evaluation Metrics
The IEEE Standard and Amendment derives its criteria based on AAMI/ANSI/ISO standards and provides comparison between IEEE, AAMI/ANSI/ISO, and BHS. An informative figure can be found in Annex A.1 Figure A.2 of IEEE Std 1708-2014 and Annex D.1 Figure D.1 of IEEE Std 1708a-2019.