GB 9706.236-2021
ActiveMedical electrical equipment—Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
医用电气设备 第2-36部分：体外引发碎石设备的基本安全和基本性能专用要求
Application Summary AI generated
This standard specifies the basic safety and essential performance requirements for medical electrical equipment used in extracorporeally induced lithotripsy, such as lithotripters that break kidney stones using shock waves. It is applied in clinical settings for the design, manufacturing, and testing of these devices to ensure patient and operator safety during stone fragmentation procedures. The standard also covers risk management and performance criteria specific to shock wave generation and delivery systems.
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