E DIN EN ISO 80601-2-12 VDE 0750-2-12:2021-11

This document applies to the basic safety and the essential performance characteristics of ventilators together with their accessories, the combination of which is hereinafter referred to as ME device and which are intended for the following:
- for those patients who may be dependent on artificial ventilation;
- For use in an environment that provides special care for patients whose condition may be life-threatening and who may require extensive care and continuous monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, this includes patient transportation within a professional healthcare facility (i.e. a ventilator that is operable while moving).
NOTE 2 An intensive care ventilator intended for transportation within a professional healthcare facility is not considered an emergency or ambulance ventilator.
- for operation by a medically trained operator.
NOTE 3 Such ventilators are considered to be life support.
NOTE 4 For the purposes of this document, such an environment is referred to as an intensive care environment.