CEN - EN ISO 27427
Anaesthetic and respiratory equipment - Nebulizing systems and components
|Publication Date:||1 September 2019|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
*This International Standard 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 International Standard 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 International Standard does not specify the minimum performance of nebulizing systems.
*This International Standard does not apply to devices intended for nasal deposition.
This International Standard does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE ISO 8185 covers this.
*This International Standard does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).
Throughout this International Standard, text for which rationale is provided in Annex A is indicated by an asterisk (*).