標準號：ISO/TR 22979-2006
中文標準名稱：眼科植入物.眼內透鏡.眼內透鏡設計改進的臨床研究需要的評定指南
英文標準名稱：Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
標準類型：C32
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C32
國際標準分類號：11.040.70
適用范圍：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.