UNE-EN ISO 80601-2-72:2023

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 part of ISO 80601 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 the home healthcare environment;

NOTE 2 In the home healthcare environment, the supply mains driving the ventilator is often not reliable.

NOTE 3 Such ventilators can also be used in non-critical care applications of professional healthcare facilities.

intended for use by a lay operator; and

intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

A 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 part of ISO 80601 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.

EXAMPLE Breathing tubes, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, and distributed alarm system.

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 part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in

IEC 60601-1:2005+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.

This part of ISO 80601 does not specify the requirements for:

ventilators or accessories 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 emergency and transport which are given in ISO 80601-2-84;

ventilators or accessories intended for homecare ventilatory support equipment 112 (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and

ISO 80601-2-80;

obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;

high-frequency ventilators, which are given in ISO 80601-2-87.

respiratory high-flow therapy equipment, which are given in ISO 80601-2-90;

NOTE 6 An ISO 80601-2-72 ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.

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 and iron-lung ventilators.

201.1.2 Object

Replacement:

The object of this part of ISO 80601 is to establish particular basic safety and essential performance requirements for a ventilator, as defined in 201.3.217, and its accessories.

Accessories are included because the combination of the ventilator and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of a

ventilator.

NOTE 1 This document has been prepared to address the relevant essential principles[31] and labelling[32] 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 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[33] as indicated in Annex EE.