GB 9706.208-2021
ActiveMedical electrical equipment –Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
医用电气设备 第2-8部分：能量为10kV至1MV 治疗X射线设备的基本安全和基本性能专用要求
Application Summary AI generated
This standard specifies safety and performance requirements for therapeutic X-ray equipment operating between 10 kV and 1 MV, covering devices used in radiation oncology for cancer treatment. It is applied by manufacturers and testing laboratories to ensure the basic safety and essential performance of linear accelerators, orthovoltage units, and superficial X-ray therapy systems. The standard is mandatory for market access in China, governing design, production, and compliance testing for medical electrical equipment in clinical radiotherapy settings.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.