ISO/FDIS 80601-2-69

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.

EXAMPLE1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function.

EXAMPLE2 An oxygen concentrator used with a flowmeter stand.

EXAMPLE3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2].

EXAMPLE4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.

This 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.

NOTE2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.

This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.

If 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.

Hazards 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.

NOTE3 See also 4.2 of the general standard.