EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 27427 standard. The EN ISO 27427 standard specifies requirements for the safety and performance testing of general-purpose nebulization systems intended for continuous or breath-hold operation of liquids in aerosol form to humans via the respiratory system.
EN ISO 27427, for example compressors, pipeline systems, cylinders etc. gas-powered nebulizers and electrically-powered nebulizers [e.g. It includes rotating disc, ultrasonic, vibrating mesh (active and passive), and capillary devices or manually operated nebulizers.
This international standard describes the requirements for the safety and performance testing of general purpose nebulization systems that are designed to be operated continuously or by breathing through the respiratory system and are intended to be used to deliver liquids in aerosol form by evaporating humans.
These medical devices, called nebulizers, convert the medicines in liquid form to vapor and reach the lungs with the effect of compressed air produced by the device. It also relaxes the airways.
Nebulizer device works with sound waves (ultrasonic) or compressed air. In both cases, liquid medications are evaporated and they are taken by inhalation. Some drugs are produced in special pharmaceutical forms for use with a nebulizer.
The general structure of the EN ISO 27427 standard mainly includes the following topics: general requirements, test requirements, test methods and alternatives, risk management, electrical safety, mechanical safety, pneumatic safety, protection against accidental settings, protection against infection, usability, marking and instructions for use. , symbols, instructions for use, manufacturing requirements, materials, connectors, regular checks, cleaning, sterilization and disinfection, and biocompatibility.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
