标准摘要
[中文适用范围]: 本文件规定了人工晶状体(IOL)材料生物相容性评估的特殊要求,包括生产它们的加工条件。 这些要求包括与生物相容性相关的理化特性的评估。 它还提供了进行眼部植入测试的指导。 [外文原描述]: This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
英文名称Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility