EN ISO 27427:2023

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.NOTE1 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).NOTE2 ISO 20072 covers these devices.NOTE3 See Annex A for rationale.