TS EN 13544-3 + A1 Respiratory Therapy Devices - Part 3: Air Distribution Devices

The European standard EN 13544-3 describes the basic safety and performance characteristics and test methods of air distribution devices within the scope of respiratory therapy equipment. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 13544-3 + A1 Respiratory therapy devices - Part 3: Air distribution devices. For the same requirements, later published by the International Standards Organization (ISO) ISO / DIS 23372 Respiratory therapy devices - Air distribution devices standard for the same requirements.

The EN 13544-3 standard specifies the minimum performance and safety requirements of nebulization systems used to deliver a certain oxygen concentration to patients. This standard provides a test method for checking the oxygen concentration in the air and oxygen mixture generated by the nebulization system. This standard also describes marking requirements and offers an optional color coding system to help the user identify the specified oxygen concentration. However, this standard does not cover nebulization equipment that is integrated with medical devices in other standards, such as emergency lung ventilators, humidifiers and other nebulizers.

Air distribution devices, which are among the respiratory therapy devices, help patients to breathe more effectively. Patients who have mechanical difficulties that make it difficult to get enough oxygen in their lungs and trachea need this. In cases where respiratory assistance is required, it is sometimes necessary to open the airway to deliver oxygen and intubation, that is, to insert a tube into the trachea. Ventilators regulate the amount of oxygen the patient receives and even how often the patient breathes.

Nebulizers are hand-held devices with air flow meters that measure oxygen flow. These devices vaporize a certain drug mixture and deliver it to the patient in a fine mist or steam. These devices are generally used in hospitals.

Within the scope of laboratory services, our organization also provides basic safety and performance testing services of air distribution devices within the scope of EN 13544-3 respiratory therapy equipment.