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immediate downloadReleased: 2018-05-15
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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| Standard number: | BS EN ISO 11979-10:2018 |
| Pages: | 26 |
| Released: | 2018-05-15 |
| ISBN: | 978 0 580 92916 8 |
| Status: | Standard |
DESCRIPTION
BS EN ISO 11979-10:2018
This standard BS EN ISO 11979-10:2018 Ophthalmic implants. Intraocular lenses is classified in these ICS categories:
- 11.040.70 Ophthalmic equipment
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:
Phakic monofocal (PIOL);
Phakic multifocal (PMIOL); and
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.