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I.S. EN ISO 11979-10:2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR CORRECTION OF AMETROPIA IN PHAKIC EYES (ISO 11979-10:2018)
Amended by

I.S. EN ISO 11979-10:2006/A1:2014

Available format(s)

Hardcopy , PDF

Superseded date

07-10-2020

Language(s)

English

Published date

01-01-2007

Publisher

National Standards Authority of Ireland

Preview

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.

National Foreword
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

Defines requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.

DocumentType
Standard
Pages
28
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

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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Hardcopy - English
PDF - English
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