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.