scope:

This International Standard specifies requirements for the safety, performance and testing for general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in an 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-powered nebulizers.

*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.

*This International Standard does not apply to drug-specific nebulizers (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers and their components).