标准编号:ISO 27427:2013

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:2013-12

标准范围

*This International Standard 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 International Standard 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 powerednebulizers.This International Standard does not specify the minimum performance of nebulizing systems.*This International Standard does not apply to devices intended for nasal deposition.This International Standard does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol form.NOTE ISO 8185 covers this.[3] *This International Standard does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).

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