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BS EN ISO 11979-10:2018

BS EN ISO 11979-10:2018

$142.49

Ophthalmic implants. Intraocular lenses – Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes

Published By Publication Date Number of Pages
BSI 2018 26
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 Optical requirements
5 Mechanical requirements
6 Biocompatibility requirements
7 Shelf-life and transport stability requirements
8 Fundamental requirements
11 9 Justification for a clinical investigation
10 General clinical requirements
10.1 General
10.2 Design of a clinical investigation
10.2.1 Requirements for all types of phakic IOLs
10.2.2 Additional requirements for PTIOLs
12 10.2.3 Additional requirements for PMIOLs
10.3 Characteristics
10.3.1 General
10.3.2 Characteristics applying to the clinical evaluations for all types of phakic IOLs
13 10.3.3 Additional characteristics applying to PTIOLs
10.3.4 Additional characteristics applying to PMIOLs
10.4 Duration of the investigation
10.5 Enrolment
10.6 Bilateral implantation
14 10.7 Surgical technique
10.8 Examination and treatment of subjects
10.9 Adverse events reports
10.10 Inclusion and exclusion criteria
10.10.1 General criteria for all phakic IOLs
17 10.10.2 Additional criteria for PTIOLs
10.10.3 Additional criteria for multifocal IOLs
11 Information supplied by the manufacturer
18 Annex A (informative) Elements in a phakic IOL clinical investigation
24 Annex B (informative) Statistical methods and sample size calculations
25 Bibliography

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BS EN ISO 11979-10:2018
$142.49