Full 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 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 use 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 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.