UNE-EN ISO 80601-2-84:2025

201.1 Scope, object and related standards

IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:

201.1.1 Scope

Replacement:

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

This document applies to the basic safety and essential performance of an EMS ventilator in combination

with its accessories, hereafter also referred to as ME equipment:

¾ð intended for patients who need differing levels of support from artificial ventilation including

ventilator-dependent patients;

¾ð intended to be operated by a healthcare professional operator;

¾ð intended for use in the EMS environment; and

¾ð intended for invasive or non-invasive ventilation.

NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility.

An EMS 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

the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can

affect the basic safety or essential performance of the EMS ventilator.

NOTE 3 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+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.

This document does not specify the requirements for the following:

¾ð ventilators or accessories intended for ventilator-dependent patients in critical care applications,

which are given in ISO 80601-2-12[17].

ventilators or accessories intended for ventilator-dependent patients in the home healthcare

environment, which are given in ISO 80601-2-72[20].

¾ð ventilators or accessories intended for anaesthetic applications, which are given in

ISO 80601-2-13[18].

¾ð ventilators or accessories intended for ventilatory support equipment (intended only to augment the

ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79[21] and

ISO 80601-2-80[22] 1.

¾ð obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70[19].

¾ð user-powered resuscitators, which are given in ISO 10651-4[8].

¾ð gas-powered emergency resuscitators, which are given in ISO 10651-5[9].

¾ð continuous positive airway pressure (CPAP) ME equipment .

¾ð high-frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87[23].

¾ð high-frequency oscillatory ventilators (HFOVs)[43], which are given in ISO 80601-2-87[23].

NOTE 5 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation

modes.

¾ð cuirass or iron-lung ventilators.

201.1.2 Object

Replacement:

The object of this particular document is to establish basic safety and essential performance requirements

for an EMS ventilator, as defined in 201.3.201, and its accessories.

Accessories are included because the combination of the EMS ventilator and the accessories needs to have

acceptable risk. Accessories can have a significant impact on the basic safety or essential performance of

an EMS ventilator.

NOTE 1 This document has been prepared to address the relevant essential principles[37] and labelling[38]

guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.

NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance of

ISO 16142-1:2016[13] as indicated in Annex DD.

NOTE 3 This document has been prepared to address the relevant general safety and performance requirements

of European regulation (EU) 2017/745[39].