This Particular Standard specifies the safety requirements for VENTILATORS, as defined in
2.1.125, intended for use in critical care settings.
Continuous positive airway pressure (CPAP) devices, sleep apnea therapy devices, supportcare
VENTILATORs, emergency and transport VENTILATORs, jet and high frequency VENTILATORs
and oscillators are outside the scope of this Particular Standard, nor are devices that may be
used within hospitals, intended solely to augment the ventilation of spontaneously breathing
PATIENTS. Standards for other types of VENTILATORs, e.g. high frequency jet and oscillation
ventilators, are under consideration.
Requirements for VENTILATORs intended for anaesthetic applications are given in IEC 60601-2-13.
BS EN 60601-2-12:2006 history
2011BS EN ISO 80601-2-12:2011 Medical electrical equipment. Particular requirements for basic safety and essential performance of critical care ventilators
2006BS EN 60601-2-12:2006 Medical electrical equipment - Particular requirements for the safety of lung ventilators - Critical care ventilators
1997BS EN 794-1:1997 Lung ventilators - Particular requirements for critical care ventilators