BS PD ISO/TR 22979:2017
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Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
BSI Group , 09/21/2017
Pages: 28
BS PD ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of InternationalStandards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk managementprocess of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] Italso suggests methods of data analysis and interpretation that can be used to determine the need for aclinical investigation and its design.Cross References:ISO 11979-1:2012 ED3ISO 11979-10:2006 Ed 1ISO 14971:2007ISO 11979-2:2014 ED2ANSI/AAMI HE75:2009ISO 11979-5:2006 (R10) Ed 2ISO 11979-8:2017ISO 13485:2016ISO 11979-3:2012 ED3ISO 11979-6:2014 ED3ISO 11979-7:2014 ED3ISO 11979-4:2008 Ed 2ISO 11979-9:2006 Ed 1IEC 62366-1:2015
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