Title 21: Food and Drugs
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/ PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
/ Subpart F - General Hospital and Personal Use Therapeutic Devices / § 880.5725 Infusion pump.
§ 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).