ISO 80601-2-72:2023

Current Revision
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

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ISO 80601-2-72:2023

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

PUBLISH DATE 2023
ISO 80601-2-72:2023

This document 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; and
  • intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

This document 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.

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