GB 4505-1984
Abolished
YY/T 1933-2024
Active
Industry standards-Medicine
YY/T 1933-2024 Particular specification for MR injector
YY/T 1933-2024 Particular specification for MR injector
Basic Information
Standard Code:
YY/T 1933-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical electronic instruments and equipment
ICS Name:
X-ray imaging equipment
Publish Date:
2024-07-08
Implement Date:
2025-07-20
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电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Pages:
20 pages
Scope
本文件规定了磁共振（MR）造影注射装置（以下简称注射装置）的要求，描述了相应的试验方法。本文件适用于注射装置。本文件不适用于注射装置专用的一次性使用高压造影注射器及其附件。
Development Information
Drafting Units:
江苏省医疗器械检验所、上海市医疗器械检验研究院、南京巨鲨显示科技有限公司、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、拜耳医药保健有限公司、四川大学华西医院、重庆医科大学附属第一医院、浙江大学医学院附属第一医院、江苏省人民医院
Drafting Persons:
刘明媛、刘茹、董贇、汪剑光、金玉博、王晶、鲁宗晋、李真林、吕发金、汪启东、李大鹏
Referenced Standards
GB 9706.224-2021 Medical electrical equipment—Part 2-24:Particular requirements for the basic safety and essential performance of infusion pumps and controllers
YY/T 0482-2004 Technical requirements and test methods for magnetic resonance equipment for medical diagnosis
YY/T 0482-2010 Magnetic resonance equipment for medical imaging—Part 1:Determination of essential image quality parameters
YY/T 0482-2022 Magnetic resonance equipment for medical imaging—Determination of essential image quality parameters
YY/T 0935-2014 Particular specifications for CT injector
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