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ILNAS-EN ISO 16672:2015 Edition 08/2015
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
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Abstract

ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina. With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

Status

Standard - Withdrawn

Origin

Technical Committee :
CEN/TC 170 : Ophthalmic optics

Implementation

start of the vote on the project    03/04/2014   date of ratification (dor)    07/05/2015
end of the vote on the project    03/09/2014   date of anouncement (doa)    30/11/2015
start of the vote on the final project    05/02/2015   date of publication (dop)    29/02/2016
end of the vote on the final project    05/04/2015   date of withdrawal (dow)    29/02/2016


Publication Official Journal
of the Grand-Duchy of Luxembourg
31/12/2015
Reference Mémorial A N° 264

Relations

Evolutions
ILNAS-EN ISO 16672:2021

Relations to older standards
ILNAS-EN ISO 16672:2003

Relations to international standards
ISO 16672 
ISO 16672 
ISO 16672:2015 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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