I.S. EN ISO 11979-8:2017
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
Hardcopy , PDF
English
01-01-2017
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.
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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 |
| Standards | Relationship |
| ISO 11979-8:2017 | Identical |
| UNE-EN ISO 11979-8:2017 | Identical |
| DIN EN ISO 11979-8:2016-04 (Draft) | Identical |
| UNI EN ISO 11979-8 : 2011 | Identical |
| NBN EN ISO 11979-8 : 2015 | Identical |
| EN ISO 11979-8:2017 | Identical |
| NEN EN ISO 11979-8 : 2017 | Identical |
| NS EN ISO 11979-8 : 2017 | Identical |
| SN EN ISO 11979-8:2017 | Identical |
| 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) |
| 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 |
| 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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