ISO 27427:2010

Anaesthetic and respiratory equipment — Nebulizing systems and components

Scope

ISO 27427:2010 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.
ISO 27427:2010 includes gas-powered nebulizers which can be powered by, for example, 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.
ISO 27427:2010 does not apply to devices intended for nasal deposition.
ISO 27427:2010 does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol form.
ISO 27427:2010 does not apply to drug-specific nebulizers (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers and their components).