ISO 80601-2-84:2023

OVERVIEW

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

¾     intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;

¾     intended to be operated by a healthcare professional operator;

¾     intended for use in the EMS environment; and

¾     intended for invasive or non-invasive ventilation.

NOTE 2     An EMS ventilator can also be used for transport within a professional healthcare facility.

An EMS 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 the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.

NOTE 3

COMMENTS

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