GB 9706.263-2020

Active

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

医用电气设备 第2-63部分: 口外成像牙科X射线机基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.50
CCS
C43
Status
Active
Issue Date
2020-11-17
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the basic safety and essential performance requirements for dental extra-oral X-ray equipment, such as panoramic and cephalometric X-ray machines. It is applied in the design, manufacturing, and testing of these medical devices to ensure patient and operator safety during diagnostic imaging in dental clinics and hospitals. Compliance with GB 9706.263-2020 is mandatory for market access and regulatory approval in China.

Related Standards

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.