本文件规定了对用于生物降解的材料进行生物相容性评估的特殊要求 人工晶体（IOL），包括生产它们的加工条件。这些要求 包括评估与生物相容性相关的物理化学性质。它还提供 进行眼部植入试验的指南。购买本文件时可获得的所有当前修订均包含在购买本文件中。

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.All current amendments available at time of purchase are included with the purchase of this document.