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ISO/TR 22979:2017

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

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Kehtiv alates 27.04.2017
Tegevusala (ICS grupid)
11.040.70 Silmaraviseadmed
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Kuupäev
Tüüp
Nimetus
27.04.2017
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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.
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