标准摘要
[中文适用范围]: 补充:本专用标准规定了内窥镜设备及其与内窥镜用附件的互连条件的安全要求。 注:C 由于通用标准没有给出不同医疗电气设备一起使用时的应用部件的安全要求@本标准标准给出了使用内窥镜期间常见的特定互连条件的要求。 [外文原描述]: IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include: - alignment of requirements with IEC 60601-1:2005; - inclusion of essential performance requirements; - the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; - reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.
英文名称Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment