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 ...