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ILNAS-EN ISO 11979-10:2018 Edition 05/2018
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)
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Abstract

ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main categories of phakic intraocular lenses depending on the optical design: a) Phakic monofocal (PIOL); b) Phakic multifocal (PMIOL); and c) Phakic toric (PTIOL). Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye. The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs. ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 170 : Ophthalmic optics

Implementation

start of the vote on the project    26/01/2017   date of ratification (dor)    28/02/2018
end of the vote on the project    17/04/2017   date of anouncement (doa)    31/08/2018
start of the vote on the final project    07/12/2017   date of publication (dop)    30/11/2018
end of the vote on the final project    29/01/2018   date of withdrawal (dow)    30/11/2018


Publication Official Journal
of the Grand-Duchy of Luxembourg
21/06/2018
Reference Mémorial A N° 498

Relations

Relations to older standards
ILNAS-EN ISO 11979-10:2006
ILNAS-EN ISO 11979-10:2006/A1:2014

Relations to international standards
ISO 11979-10 
ISO 11979-10:2018 

International Classification for Standards (ICS codes) :

11.040.70 : Ophthalmic equipment

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