What standards cover oxygen firebreak installations?

There are three standards which relate to the installation of oxygen firebreaks:

  • ISO 8359:1996/Amd.1:2012 – Oxygen concentrators for medical use. Safety requirements

The amended ISO 8359:1996 standard describes the safety requirements for oxygen concentrators. It was recognized by the Food and Drug Administration (FDA) from January 2014 and was superseded by ISO 80601-2-69:2014 in January 2015.

More Information (http://www.iso.org)

ISO 8359:1996Amd 1:2012

  • EN ISO 8359:2009+A1:2012 – Oxygen concentrators for medical use. Safety requirements

The amended EN ISO 8359:2009 has been published as a national standard by each of the CEN (European Committee for Standardisation) national standardisation bodies.

More Information (http://www.bsigroup.com)

ISO 8359:2009

  • ISO 80601-2-69:2014 – Medical electrical equipment – Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

ISO 80601-2-69:2014 includes specific requirements that mitigate the risk of fire associated with oxygen therapy. In summary:

  1. The accessories (nasal cannula and tubing or mask and tubing) shall be provided with a means to extinguish a tubing fire and isolate the oxygen flow. This should be fitted close to the patient.
  2. A means to prevent propagation of fire into the oxygen concentrator outlet shall be provided. The means can also stop the flow of oxygen but it doesn’t have to. If a bubble humidifier is fitted to the concentrator, the means must protect the bubble humidifier too.

From 31 July 2017, EN ISO 80601-2-69:2014 will replace EN ISO 8359:2009+A1:2012 as the European harmonised standard for oxygen concentrators.

More Information (http://www.iso.org)

ISO 80601-2-69:2014

Regional information

Oxygen concentrator manufacturers need to make a 510(k) premarket submission to the US Food and Drug Administration (FDA) before placing a new concentrator on the market.
If the manufacturer chose to apply ISO 80601-2-69:2014 to demonstrate the safety of the new device, the fire safety elements of the standard are a requirement. This is because approval to market the product is based upon compliance to that standard.
Since 31 January 2013, oxygen concentrators placed on the market in European that provide a continuous flow should:

  1. Have a means to prevent propagation of fire into the oxygen concentrator outlet, and
  2. Include in the Instructions for Use an instruction that installation accessories (nasal cannula and tubing or mask and tubing) shall be provided with a means to extinguish a tubing fire and isolate the oxygen flow. This should be fitted close to the patient.