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
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.
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