ISO 80601-2-80:2024

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 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