The ISO 27427 standard, developed by the International Standards Organization (ISO), describes the basic safety and performance characteristics and test methods of nebulizing systems (systems that spray or vaporize fine spraying or vaporizing) and components, which are anesthesia and respiratory equipment. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 27427 Anesthesia and respiratory devices - Nebulization systems and components. This standard replaced the repealed TS EN 13544-1 standard.
This standard describes the safety, performance and testing requirements for general purpose nebulization systems designed to be operated to deliver continuous or exhaled liquids to humans in the form of an aerosol via the respiratory tract. This standard covers, for example, compressors, pipeline systems, cylinders and gas-powered nebulizers that can be operated by them, and electrically powered nebulizers such as spinning discs, ultrasonic, vibrating active and passive mesh, capillary devices, or manually operated nebulizers.
However, this standard does not apply to devices designed for nasal deposition, devices intended to provide humidification by providing water only in aerosol form, and for drug-specific nebulizers such as metered dose inhalers, metered liquid inhalers, dry powder inhalers and components.
In short, the main objectives of the ISO 27427 standard are:
Several standards that have been referred to as normative in the application of this standard are: ISO 5356-1, ISO 5356-2, ISO 5367, ISO 7396-1, ISO 9170-1, ISO 10524-1 and ISO 10524-3.
Our organization also provides performance testing services for nebulizer systems and their components, which are anesthesia and respiratory equipment, to businesses as part of our laboratory services, in accordance with ISO 27427 .
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