ISO 80601-2-84:2023
Ausgabedatum: 2023 11 03
Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
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