EVS-EN ISO 80601-2-12:2011

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT: intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM. intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility. NOTE 2 A critical care VENTILATOR intended for use in transport within a professional healthcare facility is not considered an emergency and transport ventilator. This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM, or to a VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. This International Standard is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes intended for patients who are not dependent on mechanical ventilation.