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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

$125.00$251.46


Published:21/09/2017

Pages:28

File Size:1 file , 2.4 MB

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 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.


Cross References:
ISO 11979-1:2012 ED3
ISO 11979-10:2006 Ed 1
ISO 14971:2007
ISO 11979-2:2014 ED2
ANSI/AAMI HE75:2009
ISO 11979-5:2006 (R10) Ed 2
ISO 11979-8:2017
ISO 13485:2016
ISO 11979-3:2012 ED3
ISO 11979-6:2014 ED3
ISO 11979-7:2014 ED3
ISO 11979-4:2008 Ed 2
ISO 11979-9:2006 Ed 1
IEC 62366-1:2015


All current amendments available at time of purchase are included with the purchase of this document.

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