1 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 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.