Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
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.
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