The EN 1060 series sets the requirements for non-invasive sphygmomanometers — devices measuring arterial pressure through a cuff, without entering a blood vessel.
Parts of the series
- 1060-1
- General requirements
- 1060-2
- Supplementary requirements for mechanical devices
- 1060-3
- Supplementary requirements for electro-mechanical systems
- 1060-4
- Test procedures to determine overall system accuracy
The accuracy requirement
The maximum permissible error is ±3 mmHg (or ±2%, whichever is greater). That limit matters: a systematic 5 mmHg error would materially skew hypertension diagnosis at population level.
The occupational health context
In an industrial workplace, a blood pressure monitor is often part of the medical room and the periodic health surveillance programme. Its calibration must be checked periodically — a mechanical gauge drifts over time, and a cuff that does not match the arm circumference introduces a systematic error.