Norme internationale
Anaesthetic and respiratory equipment — Nebulizing systems and components
Publié 14 juil. 2023
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.
Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.
Retirée · 11 déc. 2013