GB 9706.243-2021

Active

Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

医用电气设备 第2-43部分:介入操作X射线设备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
2021-02-20
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 particular safety and performance requirements for X-ray equipment used during interventional procedures, such as fluoroscopy-guided surgeries and catheter-based treatments. It is applied in hospitals and clinics to ensure that these devices minimize radiation risks to patients and operators while maintaining essential imaging capabilities. The standard governs the design, testing, and certification of interventional X-ray systems under the broader GB 9706 series for medical electrical equipment.

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.