standard byInternational Organization for Standardization , 04/01/2026
This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as MEequipment, in combination with its accessories, the combination also hereafter referred to as MEsystem.
u000bThis document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
u000bEXAMPLE1 Heated breathing tubes (heated-wire breathing tubes) or MEequipment intended to control these heated breathing tubes (heated breathing tube controllers).
u000bNOTE2 Heated breathing tubes and their controllers are MEequipment and are subject to the requirements of IEC60601 1.
u000bNOTE3 ISO5367 specifies other safety and performance requirements for breathing tubes.
u000bThis document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.
u000bNOTE4 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.
u000bEXAMPLE2 Heated humidifier incorporated into a critical care ventilator where ISO80601 2-12 also applies.
u000bEXAMPLE3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO80601 2 72 also applies.
u000bEXAMPLE4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO80601 2 70 also applies.
u000bEXAMPLE5 Heated humidifier incorporated into ventilatory support equipment where either ISO80601-2-79 or ISO80601-2-80 also apply.
u000bEXAMPLE6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO80601 2 90 also applies.
u000bThis document also includes requirements for an activeHME (heat and moisture exchanger), MEequipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
u000bNOTE5 ISO9360 1 and ISO9360 2 specify safety and performance requirements for a passive HME.
u000bNOTE6 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.
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.
u000bNOTE7 Additional information can be found in IEC60601 1:2005+AMD1:2012+AMD2:2020, 4.2.
u000bThis document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO20789.
u000bThis document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to humidify the chamber air (i.e., are not directly connected to the patient).
u000bThis document is not applicable to nebulizers used for the delivery of a drug to patients.
u000bNOTE8 ISO27427 specifies the safety and performance requirements for nebulizers.
