Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023)
医用电气设备第2-72部分:呼吸机依赖患者家庭医疗环境呼吸机基本安全和基本性能的特殊要求
发布日期:
2023-07-12
实施日期:
2023-07-12
ISO 80601-2-72:2015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:
用于家庭医疗环境;
供铺层操作员使用;
适用于依赖机械通气维持生命的患者。
ISO 80601-2-72:2015也适用于制造商计划连接到呼吸机呼吸系统或呼吸机的附件,这些附件的特性可能影响呼吸机的基本安全或基本性能。
ISO 80601-2-72:2015是IEC 60601-1和ISO/IEC 80601系列标准中的特定国际标准。
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.