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现行 ISO 19223:2019
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Lung ventilators and related equipment — Vocabulary and semantics 肺通气器和相关设备.词汇和语义学
发布日期: 2019-07-24
本文件为涉及机械通气的所有呼吸护理领域建立了术语和语义词汇表,如重症监护通气、麻醉通气、急救和运输通气以及家庭护理通气,包括睡眠呼吸暂停呼吸治疗设备。是适用的 -在肺呼吸机和呼吸治疗装置标准中, -在健康信息学标准中, -用于医用电气设备和医用电气系统上的标签, -在医用电气设备和医用电气系统使用说明书和随附文件中, -用于医疗电气设备和医疗电气系统互操作性,以及 -在电子健康记录中。 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或基本性能。呼吸机和呼吸机呼吸系统。 注:本文件也可用于与肺通气相关的其他应用,包括非电气装置和设备、研究、关键事件描述、法医分析和不良事件(警戒)报告系统。 本文件未指定呼吸治疗设备或生理闭环通气、高频通气或负压通气的特定术语;也不包括使用液体通气或体外气体交换或氧气的呼吸支持,除非认为有必要在边界概念之间建立界限。
This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable — in lung ventilator and breathing-therapy device standards, — in health informatics standards, — for labelling on medical electrical equipment and medical electrical systems, — in medical electrical equipment and medical electrical system instructions for use and accompanying documents, — for medical electrical equipment and medical electrical systems interoperability, and — in electronic health records. 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 and ventilator breathing system. NOTE This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems. This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.
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归口单位: ISO/TC 121/SC 4
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