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
This Technical Report provides guidance on the application of Parts 3, 7 and 9 of the ISO 11979 series ofInternational Standards for intraocular lenses (IOLs). It addresses factors to be considered in a risk analysis ofthe significance of modifications to anterior and posterior chamber, monofocal and multifocal, intraocularlenses. It also suggests methods of data analysis and interpretation that can be used to determine the needfor and the design of a clinical investigation.
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