scope:

*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 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 - ISO 80601-2-74 [3] and ISO 20789[[4]] cover these devices. *This document does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).