ISO 80601-2-12:2023

Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators ISO 80601-2-12:2023

Publication date:   Nov 3, 2023

Scope

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:
¾     intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 2      For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 3      For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 4      A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
¾     intended to be operated by a healthcare professional operator; and
¾     intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator 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 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 5     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.
NOTE 6     Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 7     A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
NOTE 8     See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
¾     ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
¾     ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84;
¾     ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72;
¾     ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80;
¾     obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
¾     continuous positive airway pressure (CPAP) ME equipment.
¾     high-frequency ventilators, which are given in ISO 80601‑2‑87;
NOTE 9      A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes.
¾     respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90;
NOTE 10    A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
¾     oxygen therapy constant flow ME equipment; and
¾     cuirass or “iron-lung” ventilation equipment.