GB 4505-1984
Abolished
YY/T 0128-2023
Active
Industry standards-Medicine
YY/T 0128-2023 Protective devices against diagnostic medical X-radiation—Device and tool
YY/T 0128-2023 Protective devices against diagnostic medical X-radiation—Device and tool
Basic Information
Standard Code:
YY/T 0128-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
X-ray imaging equipment
Publish Date:
2023-03-14
Implement Date:
2024-05-01
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:
18 pages
Scope
本文件规定了医用诊断X射线辐射防护装置及用具（以下简称防护装置）的要求和检验方法。
本文件适用于为使用者提供的用于屏蔽或减弱医用诊断X射线辐射的防护装置。
本文件不适用于穿戴式医用诊断X射线辐射防护用品。
注1：本文件所说的使用者包括在医用X射线管电压150 kV及以下进行放射线检查或介入操作期间的操作者（医生、技师和护士）、患者（受检者）以及患者周围其他人员。
注2： 穿戴式医用诊断X射线辐射防护用品包括但不限于：用于操作者防护的防护裙、甲状腺防护围脖、防护帽、防护手套、防护眼镜、防护面罩和用于患者防护的性腺防护裙、阴囊防护帘、卵巢防护帘、牙科用防护裙。
Development Information
Drafting Units:
北京市华仁益康科技发展有限公司、辽宁省医疗器械检验检测院、上海六晶科技股份有限公司、山东双鹰医疗器械有限公司
Drafting Persons:
张松华、孙智勇、朱玉斌、王英、王协昆、赵燕平、王越
Replace the following standards
Referenced Standards
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
YY/T 0292.1-2020 Protective devices against diagnostic medical X-radiation—Part 1:Determination of attenuation properties of materials
IEC/TR 60788
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
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
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