The BS EN 27427 standard has been developed by the International Standards Organization (ISO) to describe the properties and test methods of nebulization systems and components, which are an anesthetic, respiratory and reanimation equipment.
This standard was 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. The standard in question has replaced the BS EN 13544-1 standard, developed by the British Standards Institute (BSI).
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 TS EN ISO 27427 standard 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 use. instructions, symbols, instructions for use, manufacturing requirements, materials, connectors, regular checks, cleaning, sterilization and disinfection and biocompatibility.
Within the scope of breathing apparatus compatibility tests carried out by our organization EUROLAB, testing services in accordance with TS EN ISO 27427 standard are also provided.
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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.
