ISO 80601-2-79:2024

OVERVIEW

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 impairment, as defined in 201.3.300, 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 impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and

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

EXAMPLE 1        Patients with mild to moderate chronic obstructive pulmonary disease (COPD).

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 breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment.

EXAMPLE 2        Breathing sets, connectors, water traps, expiratory valve, humidifier, b