In the ISO 17510-1 standard developed by the International Standards Organization (ISO), the safety and performance characteristics and test methods of the equipment 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 17510-1 Sleep apnea respiratory therapy - Part 1: Sleep apnea respiratory therapy equipment.
This standard describes the equipment requirements for sleep apnea respiratory therapy used in ships, airplanes and other means of transport and healthcare facilities. This standard applies to equipment intended for use with adults and children. Devices intended for use with newborns are not covered by this standard. The jet and very high frequency ventilation and oscillation characteristics of these equipment are not considered in this standard. In addition, this standard is not valid for devices within the scope of the EN 794 standard series and for external body breathing devices (ventilators) defined in the ISO 4135 standard. Masks and application accessories are covered in the ISO 17510-2 standard.
Some of the topics covered in the ISO 17510-1 standard are: power input, basic safety categories, removable protective devices, environmental conditions, classification requirements, voltage and energy limitation, enclosures and protective covers, protective earthing, functional earthing and potential equalization, continuous leakage currents, dielectric strength, mechanical strength, moving parts, surfaces, corners and edges, stability under normal use, vibration and noise, pneumatic and hydraulic power, x-ray radiation, microwave radiation, light radiation (including lasers), infrared radiation, ultraviolet radiation, acoustic energy, electromagnetic compatibility, extreme temperatures, fire protection, electrostatic charges, biocompatibility, abnormal operating and failure conditions, and environmental testing.
Our organization also provides safety and performance testing services for the equipment used in ISO 17510-1 sleep apnea breathing treatment, within the scope of laboratory services.
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