标准编号:ISO 16672:2015

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:2015-08

标准范围

This International Standard applies to ocular endotamponades (OE), a group of non-solid implants usedin ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.With regard to the safety and efficacy of OE, this International Standard specifies requirements fortheir intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, productpackaging, product labelling and the information supplied by the manufacturer.

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