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

标准号：ISO/TR 22979-2006
中文标准名称：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
英文标准名称：Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
标准类型：C32
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C32
国际标准分类号：11.040.70
适用范围：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.