GB 4505-1984
Abolished
YY/T 0106-2021
Active
Industry standards-Medicine
YY/T 0106-2021 General specifications for medical diagnostic X-ray equipment
YY/T 0106-2021 General specifications for medical diagnostic X-ray equipment
Basic Information
Standard Code:
YY/T 0106-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
X-ray imaging equipment
Publish Date:
2021-09-06
Implement Date:
2022-09-01
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
本标准规定了医用诊断X射线机的分类和组成、要求和试验方法。
本标准适用于医用诊断X射线机。对于有国家或行业专用标准要求的医用诊断X射线机,应同时执行相应的国家或行业专用标准。
本标准不适用于X射线计算机体层摄影设备。
Development Information
Drafting Units:
辽宁省医疗器械检验检测院、国家药品监督管理局医疗器械技术审评中心、西门子医疗系统有限公司、上海联影医疗科技有限公司
Drafting Persons:
张勇、孙智勇、张庆、钱春健、刘炯、徐晓斌、黄克磊、金野
Replace the following standards
Referenced Standards
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 9706.3-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
GB 9706.11-1997 Medical electrical equipment—Part 2:Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
GB 9706.12-1997 Medical electrical equipment—Part 1:General requirements for safety 3.collateral standard:General requirements for radiation protection in diagnostic X-ray equipment
GB 9706.14-1997 Medical electrical equipment—Part 2:Particular requirements for the safety of associated equipment of X-ray equipment
GB 9706.23-2005 Medical electrical equipment—Part 2-43:Particular requirements for the safety of X-ray equipment for interventional procedures
GB 9706.24-2005 Medical electrical equipment—Part 2-45:Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
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
GB/T 19042.3-2005 Evaluation and routine testing in medical imaging departments—Part 3-3:Acceptance tests—Imaging performance of X-ray equipment for digital subtraction angiography(DSA)
YY/T 0202-2004 Medical diagnostic X-ray device for tomography
YY/T 0202-2009 Specifications for medical diagnostic X-ray device for tomography
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 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY/T 0910.1-2013 Medical electrical equipment—Medical image display systems—Part 1:Evaluation methods
YY/T 0910.1-2021 Medical electrical equipment—Medical image display systems—Part 1:Evaluation methods
YY/T 1708.1-2020 Basic requirements of communication and comformance for medical diagnostic X-ray image equipment—Part 1:General requirements
YY/T 1708.2-2020 Basic requirements of communication and conformance for medical X-ray image equipment—Part 2:X-ray equipment for computed tomography
YY/T 1708.3-2021 Basic requirements of communication and conformance for medical X-ray image equipment—Part 3:Digital radiography system
YY/T 1708.4-2021 Basic requirements of communication and conformance for medical X-ray image equipment—Part 4:Digital subtraction angiography equipment
YY/T 1708.5-2021 Basic requirements of communication and conformance for medical X-ray image equipment—Part 5:Mammography
YY/T 1708.6-2021 Basic requirements of communication and conformance for medical X-ray image equipment—Part 6:X-ray unit for oral cavity
YY/T 0291-1997 The environmental requirements and testing methods for medical X-ray equipment
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