This standard establishes requirements for materials, components, monitors and alarms, accessories, and labeling for dialysate supply and water treatment equipment. The quality of water and hemodialysis concentrate used in the system is also defined. Additionally, a guideline for the device user, with particular emphasis on water purity assurance and monitoring, is appended to this standard. Examples of devices included within the scope of this standard are dialysate supply systems, water treatment equipment, on-line water quality monitors (such as conductivity monitors), blood pressure monitors, blood leak detectors, and air detectors.