GB 4505-1984
Abolished
YY/T 0740-2022
Active
Industry standards-Medicine
YY/T 0740-2022 Particular specifications for medical X-ray angiography equipment
YY/T 0740-2022 Particular specifications for medical X-ray angiography equipment
Basic Information
Standard Code:
YY/T 0740-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
X-ray imaging equipment
Publish Date:
2022-05-18
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X射线设备及用具标准化分技术委员会(SAC/TC 10/SC 1)
Pages:
32 pages
Scope
本文件规定了具有介入操作功能的医用血管造影X射线机（简称血管机)的术语和定义、分类和组成、要求和试验方法。本文件适用于制造商声称适合血管造影检查和介入治疗的固定式安装的X射线设备。本文件不适用于具有透视引导血管介入操作的胃肠X射线机和移动式C形臂X射线机。
Development Information
Drafting Units:
上海西门子医疗器械有限公司、乐普(北京)医疗装备有限公司、国家食品药品监督管理总局医疗器械技术审评中心、辽宁省医疗器械检验检测院
Drafting Persons:
刘聪智、康杰、张宇晶、缪中荣、孙智勇、吴惠、杜洛山、王博、吕永辉
Replace the following standards
Referenced Standards
GB 9706.243-2021 Medical electrical equipment—Part 2-43:Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
GB 9706.254-2020 Medical electrical equipment—Part 2-54:Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
GB/T 19042.1-2003 Evaluation and routine testing in medical imaging departments—Part 3-1:Acceptance test—Imaging performance of X-ray equipment for radiographic and radioscopic systems
YY/T 0590.3-2011 Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1-3:Determination of the detective quantum efficiency—Detectors used in dynamic imaging
YY/T 0910.1-2013 Medical electrical equipment—Medical image display systems—Part 1:Evaluation methods
YY/T 1057-2016 General specifications for medical foot switch
DICOM 3.0 医学数字成像及通信
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/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB 10151-1988 Medical X-ray equipment—Specification for high voltage cable plug and socket connections
GB/T 10151-2008 Medical diagnostic X-ray equipment—Specifications for high voltage cable plugs and sockets
YY/T 0291-2007 Environmental requirements and test methods for medical X-ray equipment
YY/T 0291-2016 Environmental requirements and test methods for medical X-ray 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
YY/T 0291-1997 The environmental requirements and testing methods for medical X-ray equipment
YY 1057-2016 General specifications for medical foot switch
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