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ILNAS-EN ISO 16672:2021 Edition 10/2021
Ophthalmic implants - Ocular endotamponades (ISO 16672:2020)
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Abstract

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina. With regard to the safety and efficacy of OE, this document 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 - Active

Origin

Technical Committee :
CEN/TC 170 : Ophthalmic optics

Implementation

start of the vote on the project    02/08/2018   date of ratification (dor)    19/11/2019
end of the vote on the project    22/10/2018   date of anouncement (doa)    31/01/2022
start of the vote on the final project    29/08/2019   date of publication (dop)    30/04/2022
end of the vote on the final project    18/10/2019   date of withdrawal (dow)    30/04/2022


Publication Official Journal
of the Grand-Duchy of Luxembourg
26/04/2022
Reference Mémorial A N° 195

Relations

Relations to older standards
ILNAS-EN ISO 16672:2015

Relations to international standards
ISO 16672 
ISO 16672:2020 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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