标准编号：ISO 16672:2020
中文名称：眼科植入物 眼内填充物
英文名称：Ophthalmic implants — Ocular endotamponades
发布日期：2020-06
标准范围
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.
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