Content Description

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 ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories:

—    intended for use in the home healthcare environment;

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

NOTE 3     Such ventilatory support equipment can also be used in professional health care facilities.

—    intended for use by a lay operator;

—    intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;

—    intended for transit-operable use; and

—    not intended for patients who are dependent on artificial ventilation for their immediate life support.

EXAMPLE 1        Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.

Ventilatory support equipment 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 those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.

EXAMPLE 2        Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.

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+AMD1:2012+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.

NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 

This document does not specify the requirements for:

—    ventilators or accessories for ventilator-dependent patients 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 the emergency medical services environment, which are given in ISO 80601 2 84;

—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2 72;

—    ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601 2 79;

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

—    high-frequency jet ventilators (HFJVs), which are given in ISO 80601 2 87;

—    high-frequency oscillatory ventilators (HFOVs);

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

NOTE 6     Ventilatory support equipment 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 or “iron-lung” ventilation equipment.

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