标准摘要
ISO/IEC 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.
英文名称Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients