IEC 60601-2-16

The particular standard for dialysis machines. Its protective systems include the venous air detector and clamp, the blood leak detector, dialysate conductivity and temperature monitoring independent of the control system, the ultrafiltration control and the pressure monitors. Water quality is outside the machine and is covered by ISO 23500 (water, concentrates, dialysis fluid), which sets limits such as total chlorine at most 0.1 mg/L.

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.