Technical Standard

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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 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.

Product Details

Published:

09/21/2017

ISBN(s):

9780580853432

Number of Pages:

28

File Size:

1 file , 2.4 MB

Same As:

ISO/TR 22979:2017

Product Code(s):

30295034, 30295034, 30295034