标准号：ISO/TR 22979-2006
实施状态：作废
中文名称：眼科植入物.眼内透镜.眼内透镜设计改进的临床研究需要的评定指南
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
被替代标准：ISO/TR 22979-2017
采用标准：PD ISO/TR 22979-2008,IDT;FD S94-754-2008,IDT;DS/ISO/TR 22979-2015,IDT;NPR-ISO/TR 22979-2006 en-2006,IDT
起草单位：ISO/TC 172
标准简介：This Technical Report 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.
文件格式：PDF
文件大小：272.47KB
文件页数：24
（以上信息更新时间为：2019-11-22）
ISO_TR 22979-2006 眼科植入物.眼内透镜.眼内透镜设计改进的临床研究需要的评定指南.pdf
(272.47 KB)
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