*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).

Cross References:
ISO 10993-1
EN 15908
ISO 11137-2
IEC 60601-1:2005
EN 13544-2
ISO 11607-1
ISO 5356-1
ISO 15001
ENV 737-6
ISO 15223-1
IEC 60601-1-8
CGA V-5:2005
IEC 60601-1-6
EN 556-1
IEC 60601-1-2:2006
ISO 5356-2
ISO 14971
ISO 23328-1
ISO 11137-1
ISO 11135-1
IEC 62366
ISO 7396-1
BS EN ISO 80369-1:2018
ISO 11137-3:2017
ISO 10524-3:2019
ISO 9170-1:2017
ISO 5367
BS EN ISO 10524-3:2019
ISO 17665-1
ISO 80369-1:2018
ISO 10524-1:2018
ISO 14937
ISO 10993-19
ISO 10993-14
ISO 11737
NFPA 53M
ISO 10993-15
ISO 10993-20
IEC 60601-1-4
ISO 10993-3
ISO 15002
ISO 80601-2-13
ISO 14155
ISO 10993-13
IEC 61672-1
ISO 80369-2
ISO 13485:2003
ISO 10993-17
ISO 10993-9
ISO 8185
ISO 9276-1
ISO 10993-11
ISO 10993-10
IEC 61010
ISO 9276-2
ISO 10993-2
IEEE 11073
ISO 20072:2009
ISO 11607
IEC 60417
ISO 10993-6
ISO 14644
ISO 10993-16
TR 60878
ISO 10993-18
ISO 22442
ISO 13408
ISO 80601-2-12
ISO 14160
ISO 13485
ISO 5361
ISO 10993-12
TR 14969
EN 13544-1
ISO 3744
ISO 10993-4:2017
EN 1041:2008
ISO 10993-7
ISO 17664:2017
ISO 10993-5


Incorporates the following:
Corrigendum, September 2019