Medical electrical equipment - Part 2 84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

ISO 80601-2-84 applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: intended for patients who need differing levels of support from artificial ventilation including ventilator - dependent patients; - intended to be operated by a healthcare professional operator; - intended for use in the EMS environment; and - intended for invasive or non-invasive ventilation. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.