ISO 15798:2022 眼科植入物 眼科手术用粘弹剂

标准编号：ISO 15798:2022

中文名称：眼科植入物 眼科手术用粘弹剂

英文名称：Ophthalmic implants — Ophthalmic viscosurgical devices

发布日期：2022-01

标准范围

本文件适用于眼科粘液外科设备（OVD），这是一类具有粘性和/或粘弹性的外科侵入性医疗设备，拟在人眼眼前段手术期间使用。OVD设计用于创造和维持空间，保护眼内组织，并在手术期间操纵组织。本文件规定了与预期性能、设计属性、临床前和临床评估、灭菌、产品包装、产品标签和这些设备制造商提供的信息有关的安全要求。

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.

标准预览图