NF EN ISO 27427, S90-274 (08/2023)

This document specifies requirements for the safety, performance and testing of general purpose nebulizer systems intended for the continuous or breath-triggered administration of liquids in aerosolized form to persons via the system. respiratory. This document includes pneumatic nebulizers which can be powered, for example by compressors, by medical gas network, by bottles, etc. as well as electric nebulizers [e.g. rotating disc, ultrasonic, vibrating screen (active and passive) and capillary devices] or manual nebulizers. This document does not specify electrical requirements for electric nebulizers. This document does not specify minimum performance for nebulization systems. This document does not apply to: (a) nasal treatment devices; (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) nebulizers specific to drugs or their components (e.g. metered dose inhalers, liquid metered dose inhalers, dry powder inhalers). NOTE 2 ISO 20072 covers these devices. NOTE 3 See Annex A for justifications.
(Automatic translation from French)