ISO 80601-2-72 with its accessories applies to the basic safety and basic performance of a ventilator. Hereinafter referred to as me equipment. It is designed for use in the home healthcare environment.
It is intended for use in patients who are dependent on mechanical ventilation for life support, intended for use by an ordinary operator. ISO 80601-2-72 is also applicable to accessories that are intended by the manufacturer to be connected to the ventilator breathing system or ventilator and where the characteristics of these accessories may affect the basic safety or basic performance of the ventilator.
ISO 80601-2-72, together with its accessories, applies to the essential safety and essential performance of a ventilator, hereinafter referred to as me equipment.
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