Automatic equipment that is intended to augment or provide ventilation of the lungs of the patient when connected to the airway of the patient:
- 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;
- intended to be operated by a healthcare professional operator; and
- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
See e.g. EN ISO/IEC 80601-2-12:2011 + Cor.:2011
[Definition according to MDCG 2020-9 No. 2.1]