ČSN EN ISO 80601-2-79

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY IMPAIRMENT, as defined in 201.3.202, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES: - intended for use in the HOME HEALTHCARE ENVIRONMENT; - intended for use by a LAY OPERATOR; and - intended for use with PATIENTS who have VENTILATORY IMPAIRMENT, the most fragile of these PATIENTS, would not likely experience injury with the loss of this artificial ventilation; and - not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support. This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to the BREATHING SYSTEM of VENTILATORY SUPPORT EQUIPMENT for VENTILATORY IMPAIRMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT for VENTILATORY IMPAIRMENT.