Interpretation Response #14-0197 ([Philips Respironics] [Ms. Collen Witt])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Philips Respironics
Individual Name: Ms. Collen Witt
Location State: PA Country: US
View the Interpretation Document
Response text:
Colleen L. Witt
Manager, Regulatory Affairs
Philips Respironics
1740 Golden Mile Highway
Monroeville, PA 15146
Ref. No. 14-0197
Dear Ms. Witt:
This responds to your October 13, 2014 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to a portable oxygen concentrator (POC). Specifically, you inquire about obtaining approval from the Pipeline and Hazardous Materials Safety Administration (PHMSA) and the Federal Aviation Administration (FAA) to allow a passenger to carry and operate the POC aboard an aircraft.
According to your letter, the POC (trade name Respironics SimplyGo Mini POC) is a device that is for use by patients requiring high concentrations of oxygen on a supplemental basis. The maximum operating pressure of the Respironics SimplyGo Mini POC is 20.0 pounds per square inch (psig). The Respironics SimplyGo Mini POC is powered by multiple sources, including AC or DC power, and a rechargeable lithium ion battery pack. For the Respironics SimplyGo Mini POC powered by the rechargeable lithium ion battery pack, the standard battery pack has a Watt-hour (Wh) rating of 97.9 (3.4 ampere-hour (Ah) x 3.6 volts (V) x 8 cells). The lithium ion battery pack meets the appropriate testing requirements of the United Nations Manual of Tests and Criteria, and the battery pack is packaged in a manner to prevent short circuits when offered for transport or carried onboard an aircraft. You ask whether the POC is regulated under the HMR.
Based on the information provided in your letter, the Respironics SimplyGo Mini POC is not subject to the HMR as a Division 2.2 non-flammable gas. The standard lithium ion battery pack used to operate the device conforms to § 172.102(c)(1)(i) Special Provision 188, for the transportation of small lithium ion cells and batteries and the POC contains no other hazardous materials. Therefore, the Respironics SimplyGo Mini POC is not subject to any other requirements in the HMR.
Please note that notwithstanding the passenger exception in § 175.10(a)(18) of the HMR, Special Federal Aviation Regulation 106, "Rules for Use of Portable Oxygen Concentrator Systems on Board Aircraft" (SFAR 106) apply and are under the purview of the FAA. This response satisfies only one requirement in the FAA approval process before a POC may be operated onboard an aircraft. You may contact Ms. DK Deaderick in FAA's Flight Standards Service at (202) 267-7480 for questions regarding FAA's approval process.
I trust this satisfies your inquiry. Please contact us if we can be of further assistance.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
172.102(c)(1)(i), 175.10(a)(18)