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,_

NOTE 1 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.

NOTE 2 For the purposes of this document, such a _ventilator_ can provide transport within a _professional healthcare facility_ (i.e. be a _transit-operable_ _ventilator_).

NOTE 3 A critical care _ventilator_ intended for use in transport within a _professional healthcare facility_ is not considered as an _emergency medical services environment_ _ventilator_.

* 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 safety_ or _essential performance_ of the _ventilator_.

NOTE 4 If a clause or subclause is specifically intended to be applicable to _ME equipment_ only, or to _ME systems_ 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 _ME equipment_ and to _ME systems_, as relevant.

_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, 7.2.13 and 8.4.1.

NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

This document is not applicable to _ME equipment_ or an _ME system_ operating in a _ventilator-operational mode_ solely intended for _patients_ who are not dependent on artificial ventilation.

NOTE 6 A critical care _ventilator_, when operating in such a _ventilator-operational mode_, is not considered life-sustaining_._

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[2],
* _ventilators_ or _accessories_ intended for the _emergency medical services environment_, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4],
* _ventilators_ or _accessories_ intended for _ventilator-dependent_ _patients _in the _home healthcare environment__,_ which are given in ISO 80601-2-72:2015[5],
* _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[7][1],
* obstructive sleep apnoea therapy _ME equipment_, which are given in ISO 80601-2-70[9],
* _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[63],

NOTE 7 A critical care _ventilator_ can incorporate high-frequency jet or high-frequency oscillatory _ventilator-operational mode__s_.

* oxygen therapy constant flow _ME equipment_, and
* cuirass or "iron-lung" ventilation equipment.

[1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.