GB 4505-1984
Abolished
YY/T 1840-2023
Active
Industry standards-Medicine
YY/T 1840-2023 General specifications for medical magnetic resonance equipment
YY/T 1840-2023 General specifications for medical magnetic resonance equipment
Basic Information
Standard Code:
YY/T 1840-2023
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:
2023-01-13
Implement Date:
2026-01-15
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:
28 pages
Scope
本文件规定了医用磁共振成像设备的要求和试验方法。
本文件适用于超导型磁共振成像设备、永磁型磁共振成像设备及常导型磁共振成像设备。
Development Information
Drafting Units:
上海市医疗器械检验研究院、国家药品监督管理局医疗器械技术审评中心
Drafting Persons:
胡晟、杨鹏飞、杨煜、刘炯
Referenced Standards
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.227-2021 Medical electrical equipment—Part 2-27:Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
YY/T 0482-2022 Magnetic resonance equipment for medical imaging—Determination of essential image quality parameters
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
YY 9706.261-2023 Medical electrical equipment—Part 2-61:Particular requirements for the basic safety and essential performance of pulse oximeter equipment
GB 7247.1-2001 Safety of laser products—Part 1:Equipment classification, requirements and user's guide
GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
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
GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements
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