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EN ISO 11979-10:2018

Current
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)
Published date

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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