21 CFR § 868.5160 Anesthesiology Devices

§ 868.5160 Gas machine for anesthesia or analgesia.

Current through Sep 8, 2026 · Read all of Part 868

(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).

← § 868.5150 Anesthesia conduction needle.§ 868.5165 Nitric oxide administration apparatus. →