21 CFR § 880.5725 General Hospital and Personal Use Devices

§ 880.5725 Infusion pump.

Current through Sep 8, 2026 · Read all of Part 880

(a) Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

(b) Classification. Class II (performance standards).

← § 880.5700 Neonatal phototherapy unit.§ 880.5730 Alternate controller enabled infusion pump. →