EN ISO 8359 Oxygen Concentrators for Medical Use, Safety Requirements

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 8359 standard. EN ISO 8359 is a standard that defines safety requirements for oxygen concentrators.

This international standard specifies safety requirements for continuous flow oxygen concentrators. This applies to oxygen concentrators intended to supply gas to several patients through a tubular medical gas installation, or to oxygen concentrators intended to be used in the presence of flammable anesthetics or cleaning agents.

EN ISO 8359 was recently modified to include the benefits of new oxygen technology, as ISO has "new insight into the role of oxygen concentrators in precipitating home fires caused by patient smoking while undergoing oxygen therapy". ISO acknowledges that "Although these changes cannot prevent such fires, it is hoped that the severity of such fires can be reduced by these changes".

The accessory assembly that delivers gas to the patient from the oxygen concentrator should include a means to stop the flow of gas towards the patient in case the accessory ignites. Protection devices should be placed as close to the patient as reasonably practicable.

EUROLAB assists manufacturers with EN ISO 8359 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.