BS PD ISO/TR 22979:2017

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

BSI Group , 09/21/2017

Publisher: BS

File Format: PDF

$132.00$264.16

Description

Standard By:BSI Group , 09/21/2017

Published:09/21/2017

Pages:28

ISBN(s):9780580853432

File Size:1 file , 2.4 MB

Language:English

Note:This product is unavailable in Ukraine, Russia, Belarus

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