GB 9706.245-2020

Active

Medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices

医用电气设备 第2-45部分:乳腺X射线摄影设备和乳腺摄影立体定位装置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 the basic safety and essential performance requirements for mammographic X-ray equipment and mammographic stereotactic devices. It is applied in the design, manufacturing, and testing of medical electrical equipment used for breast imaging and biopsy procedures in clinical radiology settings. The standard ensures patient and operator safety, as well as image quality, for both diagnostic mammography and stereotactic-guided interventions.

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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.