ČSN EN ISO 11979-10 (195300)

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes

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STANDARD published on 1.11.2018


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The information about the standard:

Designation standards: ČSN EN ISO 11979-10
Classification mark: 195300
Catalog number: 505512
Publication date standards: 1.11.2018
SKU: NS-903480
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

The category - similar standards:

Ophthalmic equipment

Annotation of standard text ČSN EN ISO 11979-10 (195300):

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

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