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EVS-EN ISO 27427:2023

Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)

General information

Valid from 15.08.2023
Base Documents
ISO 27427:2023; EN ISO 27427:2023
Directives or regulations

Standard history

ISO 27427 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. Nebulizers are widely used to deliver drugs and vaccines in an aerosol form to humans through the respiratory system.

Nebulizers are also used for diagnostic purposes using radioisotopes for lung challenge tests. These drugs can be in the form of a solution, suspension or emulsion. Aerosol inhalation is the preferred route of administration for some drugs. Some drugs are intended for the treatment of systemic diseases and other drugs are intended to treat respiratory diseases. To achieve the intended treatment, aerosol particles are deposited in specific parts of the respiratory tract.

ISO 27427 includes gas-powered nebulizers which can be powered by compressors, pipeline systems or cylinders and electrically powered nebulizers like spinning disc, ultrasonic, vibrating mesh or capillary devices or manually powered nebulizers. ISO 27427 does not specify the electrical requirements of electrically powered nebulizers. The text of ISO 27427:2023 has been approved in Europe as EN ISO 27427:2023 without any changes.

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