眼科植入物.眼科手术设备

[中文适用范围]： 本文件适用于眼科粘性手术器械（OVD），一类具有粘性和/或粘弹性特性的外科侵入性医疗器械，旨在用于人眼眼前段手术期间使用。 OVD 旨在创造和维持空间、保护眼内组织并在手术期间操纵组织。 本文件规定了有关预期性能、设计属性、临床前和临床评估、灭菌、产品包装、产品标签以及这些设备制造商提供的信息的安全性要求。 [外文原描述]： This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery. This document specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.