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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
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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

PUBLISH DATE 2018
PAGES 26
BSI BS EN ISO 11979-10:2018

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.

SDO BSI: British Standards Institution
Document Number ISO 11979-10
Publication Date May 15, 2018
Language en - English
Page Count 26
Revision Level
Supercedes
Committee CH/172/7
Publish Date Document Id Type View
May 15, 2018 BS EN ISO 11979-10:2018 Revision
Sept. 29, 2006 BS EN ISO 11979-10:2006 Revision
Sept. 30, 2014 BS EN ISO 11979-10:2006+A1:2014 Consolidated