标准摘要
[中文适用范围]: 包括所有用于诊断、治疗或监测目的的电容放电型X射线成像系统,为国际范围内的产品一致性与安全性提供了统一的技术框架,促进了医疗设备的安全应用与监管协调。 [外文原描述]: Establishes requirements applying to capacitor discharge X-ray generators for medical radiology in which electrical energy for loading of the X-ray tube is primarily stored at and switched in the high-voltage circuit. Its object is to ensure safety and to specify methods for demonstrating compliance with the safety requirements.
英文名称Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators