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 (ISO 11979-10:2018)
02-05-2018
European foreword
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
ISO 11979-10:2018 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); andc) 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.ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.
| Committee |
CEN/TC 170
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| ISO 11979-7:2014 | Ophthalmic implants Intraocular lenses Part 7: Clinical investigations |
| ISO 11979-3:2012 | Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods |
| ISO/TR 22979:2017 | Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| ISO 11979-8:2017 | Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| ISO 11979-4:2008 | Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 11979-2:2014 | Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods |
| ISO 11979-5:2006 | Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11979-6:2014 | Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing |
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