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Anaesthetic and respiratory equipment - Nebulizing systems and components
Translate name
STANDARD published on 1.2.2024
Designation standards: ČSN EN ISO 27427
Classification mark: 852107
Catalog number: 518184
Publication date standards: 1.2.2024
SKU: NS-1165066
The number of pages: 48
Approximate weight : 144 g (0.32 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
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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