GB 4505-1984
Abolished
YY/T 1827.1-2022
Active
Industry standards-Medicine
YY/T 1827.1-2022 Medical electrical equipment—Radiation dose documentation—Part 1:Radiation dose structured reports for radiography and radioscopy
YY/T 1827.1-2022 Medical electrical equipment—Radiation dose documentation—Part 1:Radiation dose structured reports for radiography and radioscopy
Basic Information
Standard Code:
YY/T 1827.1-2022
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:
2023-06-01
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:
28 pages
Scope
本文件规定了用于报告剂量学和产生辐照影像相关信息的最小数据集,辐射剂量结构化报告(RDSR)信息的单位、数量和数据存储格式。
本文件适用于在GB 9706.243或GB 9706.254文件规定范围内的X射线设备所生成的辐射剂量结构化报告。
注1: 本文件目的是为了具有生成辐射剂量结构化报告(RDSR)能力的其他X射线成像设备制定和发布类似文件提供参考。
注2: 本文件不对报告或显示的数据的准确性规定具体要求。
注3: 规定具体数据格式是因为该数据格式与其他数据格式相比,不确定度数值可能较小。
注4: 本文件不对提供给操作者或其他人员的剂量信息显示的形式做出规定。
注5: 数据字段和报告结构是为了用于如下方面的剂量学数据的收集:显著辐射剂量程序的管理、设备质量计划、建立参考水平、教学。
注6: 公开的数据结构有利于相关组织、机构进行数据分析。
Development Information
Drafting Units:
辽宁省医疗器械检验检测院、佳能医疗系统(中国)有限公司、上海西门子医疗器械有限公司、史赛克(北京)医疗器械有限公司、上海思路迪生物医学科技有限公司
Drafting Persons:
金玉博、李巍、曹景泰、张富涛、金迪、赵佳洋、刘聪智
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
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 9706.243-2021 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
Adopt standards
IEC 61910-1:2014
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