The European standard EN 13544-2 describes the basic safety and performance characteristics and test methods of the tubing and fittings of respiratory therapy equipment. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 13544-2 + A1 Respiratory therapy devices - Part 2: Piping system and fittings. For the same requirements, the ISO / DIS 17256 Anesthetic and respiratory equipment - Respiratory therapy tubes and connectors standard was later published by the International Standards Organization (ISO) for the same requirements.
This European standard specifies the requirements for nebulization systems used to deliver medicines in the form of an aerosol to humans via the respiratory tract. For example, compressors, pipeline systems, cylinders, ultrasonic and membrane devices, or electrically powered nebulizers or manually operated nebulizers are covered by this standard. This type of medical equipment is used for treatment purposes in residences, ambulances, hospitals and healthcare institutions. This standard also includes fittings and piping systems used with this equipment.
Requirements for nebulizers with humidification function are contained in the EN ISO 8185 standard. The EN 13544-2 standard does not cover nebulizers pre-filled with specific medical equipment.
In short, the EN 13544-2 standard describes the requirements for components such as cylinders, nipples, and threaded connections used with equipment for the therapeutic application of respirable gases. These cylinders are primarily used with oxygen, air, or mixtures of these gases. The standard includes technical specifications aimed at ensuring the interchangeability of respiratory therapy equipment, thus enabling patients to receive continuous treatment in all clinical situations.
Within the scope of laboratory services, our organization also provides basic safety and performance testing services of EN 13544-2 respiratory therapy equipment piping and fittings.
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