标准摘要
[中文适用范围]: 本标准规定了用于医疗诊断和治疗的内窥镜设备和集成仪器的安全要求。它被细分为与内窥镜有关的五种应用,用于(a)直接可视化,(b)与热烧术或(c)碎石集成,(d)电外科和(e)其他专用内窥镜。 [外文原描述]: This standard specifies requirements for the safety of endoscopic equipment and integrated instrumentation used for medical diagnosis and therapy. It is subdivided into five applications concerning endoscopes for (a) direct visualization, (b) integration with thermocautery or (c) lithotrite, (d) electrosurgery and (e) other specialized endoscopes.
英文名称Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment.