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;

—    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.

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.