GB 10152-2009

Active

B mode ultrasonic diagnostic equipment

B型超声诊断设备

Standard Type
GB
ICS
11.040.50
CCS
C41
Status
Active
Issue Date
2009-11-15
Implementation
2010-12-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

GB 10152-2009 specifies the safety, performance, and testing requirements for B-mode ultrasonic diagnostic equipment used in medical imaging. It applies to devices that produce two-dimensional grayscale ultrasound images for clinical diagnosis, such as those used in obstetrics, abdominal, and cardiac examinations. The standard ensures consistent image quality and patient safety across equipment manufactured or used 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.