标准摘要
[中文适用范围]： ISO 80601 的这一部分适用于呼吸机及其配件（以下简称 ME 设备）的基本安全和基本性能，该设备： 旨在用于家庭环境中的医疗护理；供非专业操作员使用；适用于依靠机械通气维持生命的患者。 注1：此类呼吸机也可用于不依赖呼吸支持的患者。 注 2：在家庭环境中提供医疗护理时，驱动呼吸机的电源通常不可靠。 注 3：此类呼吸机也可用于专业医疗机构的非重症监护应用。 - ISO 80601 的这一部分也适用于附件制造商打算连接到呼吸机呼吸系统或连接到呼吸机的附件，其中该附件的特性可能会影响呼吸机的基本安全或基本性能。 例如：呼吸软管、连接器、聚水器、呼气阀、加湿器、呼吸系统过滤器、外部电源和分布式报警系统。 [外文原描述]： 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.
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