ČSN EN ISO 80601-2-80   (364801) Zdravotnické elektrické přístroje - Část 2-80: Zvláštní požadavky na základní bezpečnost a nezbytnou funkčnost přístrojů pro podporu ventilace při ventilační nedostatečnosti

Anotace textu normy ČSN EN ISO 80601-2-80   (364801)

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY INSUFFICIENCY, as defined in 201.3.204, 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,

- intended for use with PATIENTS who have VENTILATORY INSUFFICIENCY or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation,

- intended for TRANSIT-OPERABLE use,

- 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 VENTILATOR BREATHING SYSTEM of VENTILATORY SUPPORT EQUIPMENT for VENTILATORY INSUFFICIENCY, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT for VENTILATORY INSUFFICIENCY.