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

Publish Date: 2021-09-06 Implement Date: 2022-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 28 Thousand words Pages: 20 pages

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

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