In the ISO 17510 standard, developed by the International Standards Organization (ISO), the safety and performance characteristics and test methods of the masks and application accessories used in sleep apnea breathing treatment are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 17510 Medical devices - Sleep apnea respiratory therapy - Masks and application accessories. This standard replaced the abolished TS EN ISO 17510-2 standard.
This standard applies to masks, their fastening, and accessories used to connect a sleep apnea respiratory therapy equipment to the patient. It describes the requirements for masks and accessories, including any fasteners, required to connect the patient connection port of sleep apnea respiratory therapy equipment to a patient. In short, sleep apnea applies to the application of respiratory therapy, such as nasal masks, exhaust outlets and hoods. However, this standard does not cover oral devices.
Sleep apnea respiratory therapy devices are addressed in the ISO 17510-1 standard.
Sleep apnea is defined as stopping of breathing during sleep. Sleep is of great importance for a healthy life, and approximately one third of human life is spent in sleep. The poor quality of sleep causes continuous sleep during the day and low concentration and rarely causes heart rhythm disturbances, high blood pressure, paralysis or sudden night death. Positive air pressure therapy is used in sleep apnea treatment. Respiratory therapy devices, masks and some application accessories are used in this treatment. Adjustments are made according to the patient's condition and the patient is followed up.
Our organization also provides testing services for masks and application accessories used in sleep apnea respiratory treatment, in accordance with ISO 17510 standards, to businesses as part of our laboratory services .
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