Résumé
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards 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.
Informations générales
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État actuel: PubliéeDate de publication: 2017-05Stade: Norme internationale publiée [60.60]
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Edition: 2
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Comité technique :ISO/TC 172/SC 7ICS :11.040.70
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Cycle de vie
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Précédemment
AnnuléeISO/TR 22979:2006
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Actuellement