眼科植入物 - 眼内膜

[中文适用范围]： 本文件适用于眼内填塞物 (OE)，这是一组引入眼睛玻璃体腔的非固体手术侵入性医疗设备，用于将脱落的视网膜压平并定位到视网膜色素上皮 (RPE) 上，或填塞视网膜。 关于OE的安全性和有效性，本文件规定了其预期性能、设计属性、临床前和临床评估、灭菌、产品包装、产品标签以及制造商提供的信息的要求。 [外文原描述]： 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.