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DS/EN ISO 27427:2023
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
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.
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