ISO 16671:2003 眼科移植-眼外科冲洗溶液

标准编号：ISO 16671:2003

中文名称：眼科移植-眼外科冲洗溶液

英文名称：Ophthalmic implants — Irrigating solutions for ophthalmic surgery

发布日期：2003-05

标准范围

ISO 16671:2002定义了与预期性能、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有关的安全要求。ISO 16671:2002适用于眼科手术期间使用的眼科冲洗液（OIS）。这些溶液不提供任何主要的免疫、药理或代谢功能。

ISO 16671:2002 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.ISO 16671:2002 applies to ophthalmic irrigating solutions (OISs), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological or metabolic function.

标准预览图