GB 4505-1984
Abolished
YY/T 0482-2022
Active
Industry standards-Medicine
YY/T 0482-2022 Magnetic resonance equipment for medical imaging—Determination of essential image quality parameters
YY/T 0482-2022 Magnetic resonance equipment for medical imaging—Determination of essential image quality parameters
Basic Information
Standard Code:
YY/T 0482-2022
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:
2022-07-01
Implement Date:
2023-05-01
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电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Pages:
76 pages
Scope
本文件规定了用于测定磁共振设备的一些主要的图像质量参数的测量程序。本文件适用于:
——在验收试验时进行质量评价;
——在稳定性试验时进行质量保证。
注1:并非所有测试都提供了验收试验所需的性能等级。
本文件不适用于:
——在验收试验和稳定性试验时进行性能等级的确定;
——大于8 T的高场磁共振设备的图像质量评价,除非另有说明;
——受磁共振兼容性问题影响的图像质量;
——特殊诊断流程,如血流成像、灌注、扩散、放疗和图像引导治疗的应用;
——型式试验。
注2:本文件的范围也仅限于对测试模具上采集的图像质量特性进行测量,而不是对患者的图像。
注3:本文件中的所有方法均未在3 T以上的静磁场强度下进行广泛测试。初始测试表明,在使用适当的测试模具填充物时,这些方法可正常工作。
Development Information
Drafting Units:
上海市医疗器械检测所、西门子(深圳)磁共振有限公司、上海联影医疗科技股份有限公司、航卫通用电气医疗系统有限公司
Drafting Persons:
胡晟、王俊、邢晓聪、贺强、王坤、杨煜
Replace the following standards
Referenced Standards
IEC TR 60788:2004
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
YY 9706.233-2021 Medical electrical equipment—Part 2-33:Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Adopt standards
IEC 62464-1:2018
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