ISO 80601-2-30 and ISO 81060-2

ISO 80601-2-30 is the safety and performance standard for automated NIBP monitors: the accuracy of the cuff pressure measurement against a reference (manufacturers commonly state ±3 mmHg), a limit on maximum cuff pressure and on how long the cuff stays inflated, and alarms. ISO 81060-2 is the clinical validation protocol against a reference method: the mean difference must be within ±5 mmHg with a standard deviation of at most 8 mmHg. A monitor can pass its static pressure check and still read wrong on a patient if the cuff size is wrong, which is why cuff selection by arm circumference is part of every check.

A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.