ÖNORM EN ISO 80601-2-80

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; — intended for transit-operable use; and — not intended for patients who are dependent on artificial ventilation for their immediate life support. Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency. 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: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601-2-12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72; — ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601-2-79; — sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70; — high-frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87; — high-frequency oscillatory ventilators (HFOVs); — respiratory high flow equipment, which are given in ISO 80601-2-90; — user-powered resuscitators, which are given in ISO 10651-4; — gas-powered emergency resuscitators, which are given in ISO 10651-5; — oxygen therapy constant flow ME equipment; and — cuirass or “iron-lung” ventilation equipment.