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.
ISO 80601-2-72:2015 is a particular International Standard in the IEC 60601‑1 and ISO/IEC 80601 series of standards.
Status: Under development
Technical Committee: ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care