standard byInternational Organization for Standardization , 04/01/2026
This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, MEequipment or MEsystems.
u000bEXAMPLE1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function.
u000bEXAMPLE2 An oxygen concentrator used with a flowmeter stand.
u000bEXAMPLE3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2].
u000bEXAMPLE4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.
u000bThis document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator.
u000bNOTE2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.
u000bThis document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.
u000bIf a clause or subclause is specifically intended to be applicable to MEequipment only, or to MEsystems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEequipment and to MEsystems, as relevant.
u000bHazards inherent in the intended physiological function of MEequipment or MEsystems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
u000bNOTE3 See also 4.2 of the general standard.
