GB 4505-1984
Abolished
YY/T 1862-2023
Active
Industry standards-Medicine
YY/T 1862-2023 Particular specification of coronary CT image processing software
YY/T 1862-2023 Particular specification of coronary CT image processing software
Basic Information
Standard Code:
YY/T 1862-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
X-ray imaging equipment
Publish Date:
2023-01-13
Implement Date:
2024-01-15
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X射线设备及用具分技术委员会(SAC/TC 10/SC 1)
Pages:
28 pages
Scope
本文件规定了冠状动脉CT影像处理软件产品的要求和检验方法。
本文件适用于冠状动脉CT影像处理软件，及搭载此类软件的X射线计算机体层摄影设备及影像后处理工作站。
Development Information
Drafting Units:
辽宁省医疗器械检验检测院、上海西门子医疗器械有限公司、国家药品监督管理局医疗器械技术审评中心、数坤(北京)网络科技股份有限公司、航卫通用电气医疗系统有限公司、飞利浦医疗(苏州)有限公司、中国信息通信研究院、科亚医疗科技股份有限公司、上海杏脉信息科技有限公司、上海联影智能医疗科技有限公司
Drafting Persons:
张龙达、孙智勇、田毅、费震宇、郑晨、郑超、魏东、王怀志、闵栋、曹坤琳、房劬、詹翊强
Referenced Standards
YY/T 1708.1-2020 Basic requirements of communication and comformance for medical diagnostic X-ray image equipment—Part 1:General requirements
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 25000.10-2016 Systems and software engineering—Systems and software Quality Requirements and Evaluation(SQuaRE)—Part 10:System and softwarequality models
GB/T 25000.51-2010 Software engineering—Software product Quality Requirements and Evaluation (SQuaRE)—Requirements for quality of Commercial Off-The-Self (COTS) software product and instructions for testing
GB/T 25000.51-2016 Systems and software engineering—Systems and software Quality Requirements and Evaluation (SQuaRE)—Part 51:Requirements for quality of Ready to Use Software Product(RUSP) and instructions for testing
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