The ISO 26782 standard, developed by the International Organization for Standardization (ISO), describes the basic safety and performance characteristics and test methods of spirometers used to measure time-dependent exhaled volumes of patients. This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 26782 / AC Anesthesia and respiratory equipment - Spirometers designed to measure time-dependent exhalation volumes in humans.
This standard defines the requirements for spirometers designed for assessing respiratory function in individuals weighing more than 10 kg . The standard applies to devices used as part of an integrated pulmonary function device or as a standalone device, regardless of the measurement method employed. It covers spirometers that measure timed and time-expired volumes.
A spirometer is a medical equipment that records the physiological lung ventilation volumes of people in the vital capacity range. Spirometric assessments are used, for example, to screen people at risk for lung disease, to take objective measures in the presence of lung disease, to assess symptoms and preoperative risk, and to record the impact of therapeutic intervention. Spirometry is used in the evaluation of respiratory failure, public health and clinical studies. However, there is no recognized national or international standard for unsafe spirometers.
The ISO 26782 standard gives the user confidence that any spirometer used meets accepted standards of accuracy, repeatability, electrical safety and similar standards. The minimum safety requirements in this standard provide a practical level of safety in the operation of spirometers.
Within the scope of laboratory services, our organization also provides basic safety and performance testing services of spirometers used to measure the time-dependent exhalation volumes of ISO 26782 patients.
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