ČSN EN ISO 80601-2-72 (364801)

Kategorie - ähnliche Normen:

Anaesthetic, respiratory and reanimation equipment

Die Annotation des Normtextes ČSN EN ISO 80601-2-72 (364801):

NOTE 1 - There is guidance or rationale for this subclause contained in Clause AA.2.

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:

• - intended for use in the home healthcare environment;

NOTE 2 - In the home healthcare environment, the supply mains driving the ventilator is often not reliable.

NOTE 3 - Such ventilators can also be used in non-critical care applications of professional healthcare facilities.

- intended for use by a lay operator; and

- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

A ventilator is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

NOTE 4 - 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 for the requirements specified in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 5 - Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.

This document does not specify the requirements for:

• - ventilators or accessories intended for critical care applications, which are given in ISO 80601-2-12;
• - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13;
• - ventilators or accessories intended for emergency and transport which are given in ISO 80601-2-84;
• - ventilators or accessories intended for homecare ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and ISO 80601-2-80;
• - obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;
• - high-frequency ventilators, which are given in ISO 80601-2-87.
• - respiratory high-flow therapy equipment, which are given in ISO 80601-2-90;

NOTE 6 - An ISO 80601-2-72 ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.

- user-powered resuscitators, which are given in ISO 10651-4;

- gas-powered emergency resuscitators, which are given in ISO 10651-5;

- oxygen therapy constant flow ME equipment; and

- cuirass and "iron-lung" ventilators