GB 4505-1984
Abolished
YY/T 1625-2026
Pending
Industry standards-Medicine
YY/T 1625-2026 Particular specifications for mobile X-ray equipment for computed tomography
YY/T 1625-2026 Particular specifications for mobile X-ray equipment for computed tomography
Basic Information
Standard Code:
YY/T 1625-2026
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
X-ray imaging equipment
Publish Date:
2026-03-09
Implement Date:
2027-03-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用电器标准化技术委员会医用X射线设备及用具分技术委员会(SAC/TC 10/SC 1)
Pages:
16 pages
Scope
本文件规定了移动式X射线计算机体层摄影设备(以下简称移动CT扫描装置)的组成和要求,描述了相应的试验方法。
本文件适用于移动CT扫描装置。
本文件不适用于通过导轨移动的X射线计算机体层摄影设备、固定安装在交通运输工具上的X射线计算机体层摄影设备。
Development Information
Drafting Units:
辽宁省医疗器械检验检测院、国家药品监督管理局医疗器械技术审评中心、上海西门子医疗器械有限公司、睿联医疗科技(大连)有限公司、江苏摩科特医疗科技有限公司、中国人民解放军北部战区总医院
Drafting Persons:
高颖、王博、王晶、叶硕奇、赵海兵、范波、张立波、田毅、张勇、黄克磊
Replace the following standards
Referenced Standards
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.103-2020 Medical electrical equipment—Part 1-3:General requirements for basic safety and essential performance—Collateral Standard:Radiation protection in diagnostic X-ray equipment
GB 9706.228-2020 Medical electrical equipment—Part 2-28:Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
GB 9706.244-2020 Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB/T 19042.5-2022 Evaluation and routine testing in medical imaging departments—Part 3-5:X-ray computed tomography equipment imaging performance acceptance test and constancy test
YY/T 1766.1-2021 Image quality evaluation methods for computed tomography system—Part 1:Modulation transfer function evaluation
YY/T 1766.2-2021 Image quality evaluation methods for computed tomography system—Part 2:Low contrast resolution evaluation
YY/T 1766.3-2023 Image quality evaluation methods for computed tomography system—Part 3:Dual energy imaging and spectral application performance
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
Related Standards
GB 5579-1985
Abolished
GB 5579-1985 High-voltage cable plug and socket connections for medical X-ray equipment
GB 5665-1985
Abolished
GB 5665-1985 General specification for mechanical units of medical diagnostic X-ray equipment
GB 10151-1988
Abolished
GB 10151-1988 Medical X-ray equipment—Specification for high voltage cable plug and socket connections
GB/T 10149-1988
Active
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB 11239-1989
Replaced