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

Publish Date: 2026-03-09 Implement Date: 2027-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 23 Thousand words Pages: 16 pages

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

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