Full Description

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.

This 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.

EXAMPLE1 Heated breathing tubes (heated-wire breathing tubes) or MEequipment intended to control these heated breathing tubes (heated breathing tube controllers).

NOTE1 Heated breathing tubes and their controllers are MEequipment and are subject to the requirements of IEC60601-1.

NOTE2 ISO5367 specifies other safety and performance requirements for breathing tubes.

This 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.

NOTE3 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.

EXAMPLE2 Heated humidifier incorporated into a critical care ventilator where ISO80601-2-12[10] also applies.

EXAMPLE3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO80601-2-72[12] also applies.

EXAMPLE4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO80601-2-70[11] also applies.

EXAMPLE5 Heated humidifier incorporated into ventilatory support equipment where either ISO80601-2-79[13] or ISO80601-2-80[14] also apply.

EXAMPLE6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO80601-2-90[15] also applies.