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ISO - 27427

Anaesthetic and respiratory equipment - Nebulizing systems and components

active, Most Current
Organization: ISO
Publication Date: 15 December 2013
Status: active
Page Count: 56
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

*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.[3]

*This International Standard does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).

Document History

27427
December 15, 2013
Anaesthetic and respiratory equipment - Nebulizing systems and components
*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...
March 15, 2010
Anaesthetic and respiratory equipment — Nebulizing systems and components
This International Standard specifies requirements for the safety, performance and testing for general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in an...
May 1, 2009
Anaesthetic and respiratory equipment — Nebulizing systems and components
This International Standard specifies requirements for the safety, performance and testing for general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in an...

References

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