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ILNAS-EN ISO 15798:2013 Edition 09/2013
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
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  • 34 / copy
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Abstract

ISO 15798:2013 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants 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 intra-ocular tissues and to manipulate tissues during surgery. ISO 15798:2013 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Standard - Superseded

Origin

Technical Committee :
CEN/TC 170 : Ophthalmic optics

Implementation

start of the vote on the project      date of ratification (dor)    02/04/2013
end of the vote on the project      date of anouncement (doa)    31/12/2013
start of the vote on the final project    29/11/2012   date of publication (dop)    31/03/2014
end of the vote on the final project    01/03/2013   date of withdrawal (dow)    31/03/2014


Publication Official Journal
of the Grand-Duchy of Luxembourg
17/02/2014
Reference

Relations

Evolutions
ILNAS-EN ISO 15798:2022
ILNAS-EN ISO 15798:2013/A1:2017

Relations to older standards
ILNAS-EN ISO 15798:2010

Relations to international standards
ISO 15798 
ISO 15798 
ISO 15798 
ISO 15798 
ISO 15798 
ISO 15798 
ISO 15798:2013 
ISO 15798:2013 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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