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ISO - 27427

Anaesthetic and respiratory equipment — Nebulizing systems and components

active, Most Current
Organization: ISO
Publication Date: 1 July 2023
Status: active
Page Count: 40
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 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.

Document History

27427
July 1, 2023
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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