ČSN EN ISO 80601-2-80 (364801)

Annotation of standard text ČSN EN ISO 80601-2-80 (364801):

AMD1:2012+AMD2:2020, Clause 1, applies, except as follows:
Replacement:
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, 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 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.
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
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.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1