I.S. EN ISO 11979-10:2018
Current
The latest, up-to-date edition.
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
Hardcopy , PDF
English
21-05-2018
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Optical requirements
5 Mechanical requirements
6 Biocompatibility requirements
7 Shelf-life and transport stability requirements
8 Fundamental requirements
9 Justification for a clinical investigation
10 General clinical requirements
11 Information supplied by the manufacturer
Annex A (informative) Elements in a phakic IOL clinical investigation
Annex B (informative) Statistical methods and sample size calculations
Bibliography
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.
| Committee |
ISO/TC 172
|
| DocumentType |
Standard
|
| Pages |
34
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 11979-10:2018 | Identical |
| ISO 11979-10:2018 | Identical |
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