Standards Development

Scope

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 specifies the electrical requirements of electrically powered nebulizing systems in supplement to IEC 60601-1:2005 [12]

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 80601-2-74:2026 [2] and ISO 20789:2018 [3] cover these devices.

c)        drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).

NOTE 2 ISO 20072:2009 [4] covers these devices.

NOTE 3 See Annex A for rationale.