GB 9706.228-2020

Active

Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

医用电气设备 第2-28部分:医用诊断X射线管组件的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
2020-12-24
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 safety and performance requirements for X-ray tube assemblies used in medical diagnostic imaging equipment, such as CT scanners and radiography systems. It is applied during the design, manufacturing, and testing of these assemblies to ensure they operate safely under clinical conditions, preventing radiation hazards and electrical failures. Manufacturers and regulatory bodies in China use this standard to certify that X-ray tube assemblies meet mandatory safety benchmarks before market release.

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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.