GB 4505-1984
Abolished
YY/T 1821-2022
Active
Industry standards-Medicine
YY/T 1821-2022 Methods for calculating size specific dose estimates for computed tomography
YY/T 1821-2022 Methods for calculating size specific dose estimates for computed tomography
Basic Information
Standard Code:
YY/T 1821-2022
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:
2023-12-01
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射线设备及用具分技术委员会(SAC/TC 10/SC 1)
Pages:
17 pages
Scope
本文件规定了用于计算、显示或记录体型特异性剂量估算值、纵向位置z处的体型特异性剂量估算值、水等效直径以及纵向位置z处的水等效直径的标准化方法和要求,并规定了一种通过符合本文件规定的两个圆柱体水模体以及一个或多个仿人体模体的CT扫描数据确定纵向位置z处的参考水等效直径的方法,对于制造商实现的计算纵向位置z处的实现水等效直径的方法,通过使用本文件规定的测量对象和方法进行测试,并与纵向位置z处的参考水等效直径对比进行确认。
本文件适用于能够根据GB 9706.244的要求显示和报告CTDI vol的CT扫描装置,以及辐射剂量指数监测软件(RDIMS),用于其计算、显示和记录体型特异性剂量估算值(SSDE)及其关联参数。
注: 这种标准化对确保所报告的SSDE值之间的可比较性非常重要。
Development Information
Drafting Units:
宽腾(北京)医疗器械有限公司、上海西门子医疗器械有限公司、飞利浦医疗(苏州)有限公司沈阳分公司、辽宁省医疗器械检验检测院
Drafting Persons:
邢占峰、田毅、梁健、相会财、蔡晓鹭、黄克磊、孟昭阳
Referenced Standards
IEC/TR 60788
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 9706.244-2020 Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Adopt standards
IEC 62985:2019
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