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DIN EN ISO 11979-10

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)

active, Most Current
Organization: DIN
Publication Date: 1 August 2018
Status: active
Page Count: 26
ICS Code (Ophthalmic equipment): 11.040.70
scope:

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:

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.

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

Document History

DIN EN ISO 11979-10
August 1, 2018
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (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...
February 1, 2017
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO/DIS 11979-10:2017); German and English version prEN ISO 11979-10:2017
A description is not available for this item.
December 1, 2014
Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006 + Amd.1:2014) (includes Amendment A1:2014)
This part of ISO 11979 is applicable to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye.
November 1, 2006
Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006)
A description is not available for this item.

References

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