标准摘要
[中文适用范围]： 1 适用范围 本文件定义了与预期性能、设计特性、临床前和临床评估、灭菌、产品包装、产品标签以及制造商提供的信息相关的安全要求。本文件适用于眼科手术中使用的眼科冲洗液（OIS）。这些溶液不提供任何主要的免疫学、药理学或代谢功能。 [外文原描述]： This document 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. This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
英文名称Ophthalmic implants — Irrigating solutions for ophthalmic surgery