ISO DIS 27427
Anaesthetic and respiratory equipment — Nebulizing systems and components
|Publication Date:||19 March 2021|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
*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 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 ISO 80601-2-74  and ISO 20789[] cover these devices.
*This document does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).