GB 9706.265-2021
ActiveMedical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
医用电气设备 第2-65部分：口内成像牙科X射线机的基本安全和基本性能专用要求
Application Summary AI generated
This standard specifies the particular safety and performance requirements for dental intra-oral X-ray equipment used to capture images of individual teeth and surrounding oral structures. It is applied in clinical dentistry, dental clinics, and hospitals to ensure that such X-ray machines meet essential safety criteria for both patients and operators, including radiation protection and image quality. The standard governs the design, testing, and certification of these devices within the Chinese medical device regulatory framework.
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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.