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What is ISO 8359?

ISO 8359 is a standard that describes safety requirements for oxygen concentrators. It has recently had OxySafe Thermal Shut Off Devicesome amendments passed that effect how the oxygen concentrators are used in the home care industry.

ISO, or the International Organization for Standardization is a worldwide federation of national standard bodies that works together to create industry standards. Depending on the country, accreditation body or other organization that you belong to, you might have to comply with ISO standards. In the US, they are not federal law- but are often followed by accreditation bodies or other inspectors.

ISO 8359 was amended recently to include the benefits of new oxygen technology, and because the ISO had "new information regarding the role of oxygen concentrators in accelerating fires in the home that have been caused by patient smoking while undergoing oxygen therapy.” The ISO recognizes “Although these changes cannot prevent such fires, it is hoped that the severity of such fires can be reduced by these changes.”

The specific changes that are mentioned in the amendment are in regards to using a device that would stop the flow of gas if a fire was present.

From the Amendment:

"12) statement to the effect that the accessories setup used to deliver oxygen to the patient shall include a means to reduce the propagation of fire for the safety of the patient.
NOTE This can be achieved by incorporating a means to stop the flow of gas from the concentrator or humidifier, if provided, in the presence of fire.”

and

“ The accessories setup that delivers gas to the patient from an oxygen concentrator shall include a means to stop the flow of gas towards the patient in the case that the accessory becomes ignited. The means of protection should be located as close to the patient as reasonably practicable.

NOTE 1 This means is intended to prevent the propagation of fire towards the equipment from the accessory.…

EXAMPLE The means to stop the flow of gas towards the patient is located at the junction of the nasal cannula and the oxygen supply tubing.”

Practically speaking, this means that if an organization requires your firm to follow ISO, then you should place a fire stopping device, such as Applied’s OxySafe, as close to the patient as possible, with a cannula such as Applied’s unique 2” cannula. 

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