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  • BSI
    BS EN ISO 11979-10:2018 Ophthalmic implants. Intraocular lenses - Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
    Edition: 2018
    $435.35
    / user per year

Description of BS EN ISO 11979-10:2018 2018

This document 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:

  1. Phakic monofocal (PIOL);

  2. Phakic multifocal (PMIOL); and

  3. 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.

This document addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.



Standard NumberBS EN ISO 11979-10:2018
TitleOphthalmic implants. Intraocular lenses - Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
StatusConfirmed
Publication Date2018-05-15
ReplacesBS EN ISO 11979-10:2006+A1:2014, BS EN ISO 11979-10:2006
Identical National Standard OfISO 11979-10:2018, EN ISO 11979-10:2018
DescriptorsOphthalmology, Optical properties of materials, Lenses, Clinical testing, Diagnosis (medical), Implants (surgical), Eyes, Optics, Ophthalmic equipment
ICS11.040.70 Ophthalmic equipment
CommitteeCH/172/7
ISBN978 0 580 92916 8
PublisherBSI
Pages26

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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