YY/T 1307-2024 Active Industry standards-Medicine

YY/T 1307-2024 Medical digital X-ray image detector used in mammography

YY/T 1307-2024 Medical digital X-ray image detector used in mammography

Publish Date: 2024-07-08 Implement Date: 2025-07-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1307-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical radiation equipment

ICS Name: -

Publish Date: 2024-07-08

Implement Date: 2025-07-20

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线设备及用具标准化分技术委员会(SAC/TC 10/SC 1)

Pages: 28 pages

Scope

本文件规定了医用乳腺X射线摄影用探测器（以下简称探测器）的分类和组成、要求，描述了相应的试验方法。
本文件适用于具有单次或多次曝光成像功能的用于乳腺X射线设备的探测器，包括但不限于非晶硅探测器、非晶硒探测器、CCD（电荷耦合器件）探测器、CMOS（互补金属氧化物半导体）探测器、IGZO（铟镓锌氧化物）探测器、光子计数探测器等。
本文件不适用于：
——普通摄影用探测器和牙科摄影用探测器；
——计算机体层摄影用探测器；
——动态成像用探测器。

Development Information

Drafting Units:

辽宁省医疗器械检验检测院、江苏康众数字医疗设备有限公司、上海奕瑞光电子科技有限公司、上海品臻影像科技有限公司、国家药品监督管理局医疗器械技术审评中心

Drafting Persons:

郭柏军、柳晶波、孙智勇、何珊珊、刘建强、黄细平、李懿馨、王晶、孙鹏、周成广

Word Count: 36 Thousand words Pages: 28 pages

Replace the following standards

YY/T 1307-2016 Medical digital X-ray image detector used in mammography

Referenced Standards

GB/T 10149-1988 Terminology and symbol for medical X-ray equipment YY/T 0481-2016 Medical diagnostic X-ray equipment—Radiation conditions for use in the determination of characteristics YY/T 0590.2-2010 Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1-2:Determination of the detective quantum efficiency—Detectors used in mammography 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 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 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 0291-1997 The environmental requirements and testing methods for medical X-ray equipment

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