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Status : Active
Standard Type : Main
Document No : ISO/TR 22979:2017
Document Year : 2017
Pages : 22
Edition : 2
Section Volume : Ophthalmic optics and instruments (ISO/TC 172/SC 7.)
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International StandardDetails for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.