standard byInternational Organization for Standardization , 04/01/2026
This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as MEequipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.
u000bNOTE1 Conserving equipment can also be used in professional health care facilities.
u000bThis document is also applicable to conserving equipment that is incorporated with other equipment.
u000bEXAMPLE Conserving equipment combined with a pressure regulator[4], an oxygen concentrator[12] or liquid oxygen equipment[7].
u000bThis document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.
u000bThis document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.
u000bThis document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
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 IEC60601 1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
u000bNOTE2 Additional information can be found in IEC60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
