《医用诊断X射线管组件通用技术条件》标准检测和新旧版本对照

Standard Test of“General Specification of Medical Diagnostic X-Ray Tube Assemblies”and Comparison Between New and Old Versions

医用诊断X射线管组件是诊断类X射线设备的重要组成部件之一。随着科研技术的不断进步,原有的标准已经很难全面的对现有产品进行监管,因此新版YY/T 0609-2018《医用诊断X射线管组件通用技术条件》标准在2018年11月7日发布并于2019年11月1日实施。新标准根据产品出现的新特性,对相关技术条款进行新增、优化和完善,在产品检测、注册审评、市场监管等过程中更加严格的规范产品的安全有效性。

Medical diagnostic X-ray tube assemblies is one of the important components of diagnostic X-ray equipment.With the continuous progress of scientific research technology,the original standard has been difficult to comprehensively supervise the existing products.Therefore,the new version of YY/T 0609-2018“General Specification of Medical Diagnostic X-ray Tube Assemblies”was released in November 7,2018 and implemented in November 1,2019.According to the new characteristics of products,the new standard adds,optimizes and improves the relevant technical terms,and more strictly regulates the safety and effectiveness of products in the process of product testing,registration review and market supervision.