ÖVE/ÖNORM EN ISO 80601-2-12

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: - intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; - intended to be operated by a healthcare professional operator; and - intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic saHazards 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, 7.2.13 and 8.4.1. This document is not applicable to ME equipment or an ME system operating in a ventilatoroperational mode solely intended for patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: - 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, the future replacement for ISO 10651-3; - ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72:2015; - ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018; - obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70; - continuous positive airway pressure (CPAP) ME equipment; - high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87; - oxygen therapy constant flow ME equipment; and - cuirass or “iron-lung” ventilation equipment.fety or essential performance of the ventilator.