ISO 80601-2-72:2023 医用电气设备 第2-72部分：依赖呼吸机患者使用的家用保健呼吸机的基本安全和基本性能专用要求

标准编号：ISO 80601-2-72:2023

中文名称：医用电气设备 第2-72部分：依赖呼吸机患者使用的家用保健呼吸机的基本安全和基本性能专用要求

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

发布日期：2023-06

标准范围

ISO/IEC 80601-2-72:2023本文件适用于呼吸机及其附件（以下简称ME设备）的基本安全和基本性能:-旨在用于家庭保健环境中；-旨在供非专业操作员使用；和-适用于需要不同程度人工通气支持的患者，包括依赖呼吸机的患者。本文件也适用于制造商打算连接到呼吸机呼吸系统或呼吸机的附件，其中这些附件的特性会影响呼吸机的基本安全性或基本性能。

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.

标准预览图