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Standard

NS-EN ISO 27427:2023

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Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Edition: 2023-07
  • Version: 1
  • Document type: NAT
  • Pages
  • ICS 11.040.10
  • National Committee SN/K 122

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