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ISO DIS 27427

Anaesthetic and respiratory equipment — Nebulizing systems and components

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Organization: ISO
Publication Date: 19 March 2021
Status: active
Page Count: 47
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
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 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 [3] and ISO 20789[[4]] 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).

Document History

ISO DIS 27427
March 19, 2021
Anaesthetic and respiratory equipment — Nebulizing systems and components
*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...
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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