GB 4505-1984
Abolished
YY/T 0062.1-2024
Active
Industry standards-Medicine
YY/T 0062.1-2024 Medical electrical equipment—Diagnostic X-rays—Part 1:Determination of quality equivalent filtration and permanent filtration
YY/T 0062.1-2024 Medical electrical equipment—Diagnostic X-rays—Part 1:Determination of quality equivalent filtration and permanent filtration
Basic Information
Standard Code:
YY/T 0062.1-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
X-ray imaging equipment
Publish Date:
2024-02-07
Implement Date:
2025-03-01
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:
20 pages
Scope
本文件描述了X射线管组件的固有滤过和滤过材料质量等效滤过的测定方法，规定了X射线管组件在随附文件中的符合性声明和 X 射线管组件标记的要求，以及对滤过材料的指示和符合性声明要求。本文件适用于医疗诊断应用中高压150 kV以下的 X 射线管组件和滤过材料。对于高压大于50 kV，本文件仅适用于带有钨或钨合金靶的 X 射线管组件。
Development Information
Drafting Units:
辽宁省医疗器械检验检测院、辽宁省药品审评查验中心、西门子爱克斯射线真空技术(无锡)有限公司、复旦大学放射医学研究所、上海西门子医疗器械有限公司、杭州凯龙医疗器械有限公司、北京唯迈医疗设备有限公司、上海六晶科技股份有限公司、深圳市深图医学影像设备有限公司
Drafting Persons:
孟昭阳、迟戈、张振能、刘海宽、金玉博、刘璞、王越、余以智、刘文龙、朱玉斌、黄炜钦
Replace the following standards
Referenced Standards
IEC 61674:2012
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/T 10149-1988 Terminology and symbol for medical X-ray equipment
Adopt standards
IEC 60522-1:2020
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