GB 9706.22-2003
AbolishedMedical electricalequipment--Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
医用电气设备 第2部分: 体外引发碎石设备安全专用要求
Application Summary AI generated
This standard specifies particular safety requirements for medical electrical equipment used in extracorporeal lithotripsy, which generates shock waves outside the body to fragment kidney stones or gallstones. It applies to the design, testing, and certification of lithotripters used in hospitals or urology clinics, ensuring patient and operator protection against electrical hazards, mechanical risks, and unintended tissue damage. The standard is referenced by Chinese medical device manufacturers and regulatory bodies for type testing and market approval of such equipment.
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