EN ISO 80601-2-12:2023

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as MEequipment: ¾ 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; NOTE2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.¾ intended to be operated by a healthcare professional operator; and ¾ 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 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 thoseaccessories 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 safety or essential performance of the ventilator. NOTE5 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.Hazards 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.NOTE6 Additional information can be found in IEC60601-1:2005+AMD1:2012+AMD2:2020, 4.2.This document is not applicable to MEequipment or an MEsystem operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.This document is not applicable to MEequipment 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: NOTE8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO80601‑2‑13;¾ ventilators or accessories intended for the emergency medical services environment, which are given in ISO80601-2-84; ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO80601‑2-72; ¾ ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; ¾ obstructive sleep a