ISO 27427:2023 麻醉和呼吸设备 喷雾系统和构件

标准编号：ISO 27427:2023

中文名称：麻醉和呼吸设备 喷雾系统和构件

英文名称：Anaesthetic and respiratory equipment — Nebulizing systems and components

发布日期：2023-07

标准范围

本文件规定了通用雾化系统的安全性和性能测试要求，通用雾化系统旨在通过呼吸系统向人体连续或呼吸驱动输送气溶胶形式的液体。本文件包括气体驱动的雾化器(其可以由例如压缩机、管道系统、气缸等驱动)和电动雾化器[例如旋转盘、超声波、振动网(主动和被动)和毛细管装置]或手动驱动的雾化器。本文件未规定电动雾化器的电气要求。本文件未规定雾化系统的最低性能。本文件不适用于:A）？用于鼻腔沉积的器械；b）？仅旨在通过提供气溶胶形式的水来提供加湿或水合的设备。笔记？1？ISO 80601-2-74和ISO 20789涵盖了这些器械。c）？药物专用雾化器或其组件（如计量吸入器、计量液体吸入器、干粉吸入器）。笔记？2？ISO 20072涵盖了这些设备。笔记？3？原理见附录A。

This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.

This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers. This document does not specify the electrical requirements of electrically powered nebulizers.

This document does not specify the minimum performance of nebulizing systems.

This document does not apply to:

a)       devices intended for nasal deposition;

b)       devices intended solely to provide humidification or hydration by providing water in aerosol form.

NOTE 1        ISO 80601-2-74 and ISO 20789 cover these devices.

c)        drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).

NOTE 2        ISO 20072 covers these devices.

NOTE 3        See Annex A for rationale.

标准预览图