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I.S. EN ISO 11979-8:2017

Current
Current

The latest, up-to-date edition.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

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
1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Optical and mechanical properties
6 Biocompatibility
7 Clinical evaluation
8 Manufacturing
9 Sterilization
10 Packaging and shelf-life
11 Labeling and information
12 Documentation
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be covered

Defines fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

DevelopmentNote
Supersedes I.S. EN 13503-8. (09/2006)
DocumentType
Standard
Pages
22
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

EN ISO 11979-5:2006 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
EN ISO 11979-1:2012 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
EN ISO 11979-4:2008/A1:2012 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008/AMD 1:2012)
EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
ISO 11979-10:2006 Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
ISO 14630:2012 Non-active surgical implants General requirements
EN ISO 11979-3:2012 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)
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
EN ISO 11979-2:2014 Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
ISO 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
EN ISO 11979-6:2014 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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
EN ISO 11979-9:2006/A1:2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
ISO 11979-6:2014 Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)

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PDF - English
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