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ISO/TR 22979:2006

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

Standard Details

ISO/TR 22979:2006 provides guidance on the application of Parts 3, 7 and 9 of the ISO 11979 series of International StandardDetails 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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO/TR 22979:2006
Document Year: 2006
Pages: 19
Edition: 1

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ISO/TR 22979:2006
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