麻醉和呼吸设备 雾化系统和组件

[中文适用范围]： 本文件规定了通用雾化系统的安全性和性能测试要求，该雾化系统用于通过呼吸系统向人体连续或呼吸驱动输送液体气溶胶形式。本文件包括气动雾化器（可由压缩机、管道系统、气缸等供电）和电动雾化器[例如转盘、超声波、振动网（主动和被动）和毛细管装置]或手动供电雾化器。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)用于鼻腔沉积的设备；b)仅用于通过提供气溶胶形式的水来提供加湿或补水的设备。注 1 ISO 80601-2-74 和 ISO 20789 涵盖这些设备。 c) 药物专用雾化器或其部件（例如，定量吸入器、定量液体吸入器、干粉吸入器）。注 2 ISO 20072 涵盖这些设备。注 3 请参阅附录 A 了解其原理。 [外文原描述]： 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.