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DIN EN ISO 11979-8 E : 2015

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

01-01-2015

National foreword
National Annex NA (informative) - Bibliography
European foreword
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of Directive 93/42/EEC
         [OJ L 169] aimed to be covered
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 Labelling and information
12 Documentation
Bibliography

Gives 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.

DocumentType
Standard
Pages
15
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

DIN EN ISO 11979-6 E : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
DIN EN ISO 11979-4 E : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
DIN EN ISO 11979-5 E : 2010 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 11979-3 E : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
DIN EN ISO 11979-1 E : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)

DIN EN ISO 11979-9 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
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
DIN EN ISO 11979-2 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS (ISO 11979-2:2014)
DIN EN ISO 11979-5 E : 2010 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 11979-6 E : 2015 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
ISO 14630:2012 Non-active surgical implants General requirements
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 11979-9:2006 Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
DIN EN ISO 11979-7 E : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)
DIN EN ISO 11979-3 E : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
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
DIN EN ISO 11979-4 E : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
ISO 11979-6:2014 Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability testing
DIN EN ISO 11979-1 E : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)

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