---
kind: "section"
citation: "21 C.F.R. § 880.5725"
title: "21"
number: "880.5725"
heading: "Infusion pump."
url: "https://uscodex.org/cfr/21/880.5725"
---

# §880.5725. Infusion pump.

- (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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.