ISO 16672:2003 眼科移植-眼睛ENDOTAMPONADES

标准编号：ISO 16672:2003

中文名称：眼科移植-眼睛ENDOTAMPONADES

英文名称：Ophthalmic implants — Ocular endotamponades

发布日期：2003-02

标准范围

ISO 16672:2003适用于眼内安瓿（OEs），一组非固体植入物，用于眼科，将分离的视网膜压平并定位到脉络膜上，或填充视网膜。关于OEs的安全性和有效性，ISO 16672:2003规定了其预期性能、设计属性、临床前和临床评估、灭菌、产品包装、产品标签和制造商提供的信息的要求。

ISO 16672:2003 applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.With regard to the safety and efficacy of OEs, ISO 16672:2003 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.

标准预览图