BS PD ISO/TR 22979:2017

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.