21 C.F.R. § 868.5160

Current through April 30, 2024
Section 868.5160 - Gas machine for anesthesia or analgesia
(a)Gas machine for anesthesia -
(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.
(2)Classification. Class II (performance standards).
(b)Gas machine for analgesia -
(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).
(2)Classification. Class II (performance standards).

21 C.F.R. § 868.5160