Interpretation Response #13-0177 ([CHART-SeQual Technologies, Inc.] [Mr. Neal Maloy])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: CHART-SeQual Technologies, Inc.
Individual Name: Mr. Neal Maloy
Location State: GA Country: US
View the Interpretation Document
Response text:
September 18, 2013
Mr. Neal Maloy
Director – Quality and Regulatory Affairs
CHART-SeQual Technologies, Inc.
2200 Airport Industrial Drive, Suite 500
Ball Ground, GA 30107 USA
Ref. No.: 13-0177
Dear Mr. Maloy:
This responds to your August 26, 2013 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 Federal Aviation Administration (FAA) approval to allow a passenger to carry the POC aboard an aircraft.
According to your letter, the POC (trade name OXYWELL Oxygen System™) is a device that is for use by patients requiring high concentrations of oxygen on a supplemental basis. The maximum operating pressure of the OXYWELL Oxygen System™ is 23.7 pounds per square inch (psia). The OXYWELL Oxygen System™ is powered by multiple sources, including AC or DC power, and a rechargeable lithium-ion battery pack. For the OXYWELL Oxygen System™ powered by the rechargeable lithium-ion battery pack, the lithium-ion cells have an equivalent lithium content of 0.45 grams per cell and 7.20 grams of aggregate equivalent lithium content for the battery pack. The lithium-ion battery packs are types designed to meet the appropriate tests in the United Nations Manual of Tests and Criteria, and the battery packs are packaged in a manner to prevent short circuits when offered for transport or carried onboard passenger aircraft. You ask whether this device is regulated under the HMR.
Based on the information provided in your letter, the OXYWELL Oxygen System™ is not subject to the HMR as a Division 2.2 non-flammable gas. The lithium-ion battery pack used to operate the device appears to conform to § 172.102(c)(1), Special Provision 188, for the transportation of small lithium cells and batteries and the POC contains no other hazardous materials. Therefore, the OXYWELL Oxygen System™ 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 (SFAR 106) “Rules for Use of Portable Oxygen Concentrator Systems on Board Aircraft” apply and are under the purview of the FAA, not the Pipeline and Hazardous Materials Safety Administration. This response letter 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 SP 188, 175.10(c)(18)