ISO 80601-2-72:2015 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: - intended for use in the home healthcare environment; - intended for use by a lay operator; - intended for use with patients who are dependent on mechanical ventilation for their life support. ISO 80601-2-72:2015 is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.