Anaesthetic and respiratory equipment - Nebulizing systems and components
Abstract
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. NOTE 1 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). NOTE 2 ISO 20072 covers these devices. NOTE 3 See Annex A for rationale.
Begin
2026-01-08
WI
00215379
Planned document number
prEN ISO 27427 rev
Responsible national committee
NA 176-05-05 AA - Airways and related equipment
Responsible european committee
CEN/TC 215/WG 4 - Airway devices, related equipment and suction devices
previous edition(s)
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
2023-07
