ISO/TR 22979:2006 眼科植入物-内眼晶状体- -内眼晶状体设计修正所需临床研究的评估指南

标准编号：ISO/TR 22979:2006

中文名称：眼科植入物-内眼晶状体- -内眼晶状体设计修正所需临床研究的评估指南

英文名称：Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

发布日期：2006-02

标准范围

ISO/TR 22979:2006提供了ISO 11979系列人工晶体（IOL）国际标准第3、7和9部分的应用指南。本节讨论了前房和后房、单焦点和多焦点人工晶状体修改重要性风险分析中需要考虑的因素。它还提出了数据分析和解释的方法，可用于确定临床研究的需要和设计。

ISO/TR 22979:2006 provides guidance on the application of Parts 3, 7 and 9 of the ISO 11979 series of International Standards for intraocular lenses (IOLs). It addresses factors to be considered in a risk analysis of the significance of modifications to anterior and posterior chamber, monofocal and multifocal, intraocular lenses. It also suggests methods of data analysis and interpretation that can be used to determine the need for and the design of a clinical investigation.

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