UNE-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)
Spanish, Castilian, English
Published date
26-07-2017
Publisher
€70.80
Excluding VAT
This part of ISO 11979 specifies fundamental requirements for all types of intraocular lenses intended forsurgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.
| Committee |
CTN 91
|
| DevelopmentNote |
Supersedes UNE EN 13503-8. (03/2007)
|
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN ISO 11979-8:2016-04 (Draft) | 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 |
| I.S. EN ISO 11979-8:2017 | Identical |
| ISO 11979-8:2017 | Identical |
| 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 14155-1:2003 | Clinical investigation of medical devices for human subjects — Part 1: General requirements |
| 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 |
| 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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