本文件适用于眼内窥镜（Oyel endotamponades，OE），这是一组非固体的外科侵入性医疗设备，被引入眼睛的玻璃体腔中，以使分离的视网膜变平并定位到视网膜色素上皮（retinal色素上皮，RPE）上，或填充视网膜。 关于OE的安全性和有效性，本文件规定了预期性能、设计属性、临床前和临床评估、灭菌、产品包装、产品标签和制造商提供的信息的要求。

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina. With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.