ÖNORM EN ISO 80601-2-74

Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows. This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system. 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. 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. This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment 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. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789[6]. This 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. This document is not applicable to nebulizers used for the delivery of a drug to patients.