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ILNAS-EN ISO 15798:2022 Edition 02/2022
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
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  • 34 / copy
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Abstract

This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery. This document specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 170 : Ophthalmic optics

Implementation

start of the vote on the project    24/12/2020   date of ratification (dor)    17/01/2022
end of the vote on the project    22/03/2021   date of anouncement (doa)    31/05/2022
start of the vote on the final project    21/10/2021   date of publication (dop)    31/08/2022
end of the vote on the final project    16/12/2021   date of withdrawal (dow)    31/08/2022


Publication Official Journal
of the Grand-Duchy of Luxembourg
23/08/2022
Reference Mémorial A N° 467

Relations

Relations to older standards
ILNAS-EN ISO 15798:2013
ILNAS-EN ISO 15798:2013/A1:2017

Relations to international standards
ISO 15798:2022 
ISO 15798 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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