Oxygen and portable oxygen concentrators for medical use by passengers.
(a) A certificate holder may allow a passenger to carry and operate equipment for the storage, generation, or dispensing of oxygen when all of the conditions in paragraphs (a) through (d) of this section are satisfied. Beginning August 22, 2016, a certificate holder may allow a passenger to carry and operate a portable oxygen concentrator when the conditions in paragraphs (b) and (e) of this section are satisfied.
(1) The equipment is—
(i) Furnished by the certificate holder;
(ii) Of an approved type or is in conformity with the manufacturing, packaging, marking, labeling, and maintenance requirements of 49 CFR parts 171, 172, and 173, except § 173.24(a)(1);
(iii) Maintained by the certificate holder in accordance with an approved maintenance program;
(iv) Free of flammable contaminants on all exterior surfaces;
(v) Capable of providing a minimum mass flow of oxygen to the user of four liters per minute;
(vi) Constructed so that all valves, fittings, and gauges are protected from damage; and
(vii) Appropriately secured.
(2) When the oxygen is stored in the form of a liquid, the equipment has been under the certificate holder's approved maintenance program since its purchase new or since the storage container was last purged.
(3) When the oxygen is stored in the form of a compressed gas as defined in 49 CFR 173.115(b)—
(i) The equipment has been under the certificate holder's approved maintenance program since its purchase new or since the last hydrostatic test of the storage cylinder; and
(ii) The pressure in any oxygen cylinder does not exceed the rated cylinder pressure.
(4) Each person using the equipment has a medical need to use it evidenced by a written statement to be kept in that person's possession, signed by a licensed physician which specifies the maximum quantity of oxygen needed each hour and the maximum flow rate needed for the pressure altitude corresponding to the pressure in the cabin of the airplane under normal operating conditions. This paragraph does not apply to the carriage of oxygen in an airplane in which the only passengers carried are persons who may have a medical need for oxygen during flight, no more than one relative or other interested person for each of those persons, and medical attendants.
(5) When a physician's statement is required by paragraph (a)(4) of this section, the total quantity of oxygen carried is equal to the maximum quantity of oxygen needed each hour, as specified in the physician's statement, multiplied by the number of hours used to compute the amount of airplane fuel required by this part.
(6) The pilot in command is advised when the equipment is on board, and when it is intended to be used.
(7) The equipment is stowed, and each person using the equipment is seated, so as not to restrict access to or use of any required emergency, or regular exit or of the aisle in the passenger compartment.
(b) No person may smoke or create an open flame and no certificate holder may allow any person to smoke or create an open flame within 10 feet of oxygen storage and dispensing equipment carried in accordance with paragraph (a) of this section or a portable oxygen concentrator carried and operated in accordance with paragraph (e) of this section.
(c) No certificate holder may allow any person to connect or disconnect oxygen dispensing equipment, to or from a gaseous oxygen cylinder while any passenger is aboard the airplane.
(d) The requirements of this section do not apply to the carriage of supplemental or first-aid oxygen and related equipment required by this chapter.
(e) Portable oxygen concentrators—(1) Acceptance criteria. A passenger may carry or operate a portable oxygen concentrator for personal use on board an aircraft and a certificate holder may allow a passenger to carry or operate a portable oxygen concentrator on board an aircraft operated under this part during all phases of flight if the portable oxygen concentrator satisfies all of the requirements in this paragraph (e):
(i) Is legally marketed in the United States in accordance with Food and Drug Administration requirements in title 21 of the CFR;
(ii) Does not radiate radio frequency emissions that interfere with aircraft systems;
(iii) Generates a maximum oxygen pressure of less than 200 kPa gauge (29.0 psig/43.8 psia) at 20 °C (68 °F);
(iv) Does not contain any hazardous materials subject to the Hazardous Materials Regulations (49 CFR parts 171 through 180) except as provided in 49 CFR 175.10 for batteries used to power portable electronic devices and that do not require aircraft operator approval; and
(v) Bears a label on the exterior of the device applied in a manner that ensures the label will remain affixed for the life of the device and containing the following certification statement in red lettering: “The manufacturer of this POC has determined this device conforms to all applicable FAA acceptance criteria for POC carriage and use on board aircraft.” The label requirements in this paragraph (e)(1)(v) do not apply to the following portable oxygen concentrators approved by the FAA for use on board aircraft prior to May 24, 2016:
(A) AirSep Focus;
(B) AirSep FreeStyle;
(C) AirSep FreeStyle 5;
(D) AirSep LifeStyle;
(E) Delphi RS-00400;
(F) DeVilbiss Healthcare iGo;
(G) Inogen One;
(H) Inogen One G2;
(I) Inogen One G3;
(J) Inova Labs LifeChoice;
(K) Inova Labs LifeChoice Activox;
(L) International Biophysics LifeChoice;
(M) Invacare Solo2;
(N) Invacare XPO2;
(O) Oxlife Independence Oxygen Concentrator;
(P) Oxus RS-00400;
(Q) Precision Medical EasyPulse;
(R) Respironics EverGo;
(S) Respironics SimplyGo;
(T) SeQual Eclipse;
(U) SeQual eQuinox Oxygen System (model 4000);
(V) SeQual Oxywell Oxygen System (model 4000);
(W) SeQual SAROS; and
(X) VBox Trooper Oxygen Concentrator.
(2) Operating requirements. Portable oxygen concentrators that satisfy the acceptance criteria identified in paragraph (e)(1) of this section may be carried or operated by a passenger on an aircraft provided the aircraft operator ensures that all of the conditions in this paragraph (e)(2) are satisfied:
(i) Exit seats. No person operating a portable oxygen concentrator is permitted to occupy an exit seat.
(ii) Stowage of device. During movement on the surface, takeoff and landing, the device must be stowed under the seat in front of the user, or in another approved stowage location so that it does not block the aisle way or the entryway to the row. If the device is to be operated by the user, it must be operated only at a seat location that does not restrict any passenger's access to, or use of, any required emergency or regular exit, or the aisle(s) in the passenger compartment.
[Doc. No. 12169, 39 FR 42677, Dec. 6, 1974, as amended by Amdt. 121-159, 45 FR 41594, June 19, 1980; Docket FAA-2014-0554, Amdt. 121-374, 81 FR 33118, May 24, 2016]