EN ISO 11979-8:2017
Current
Current
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
Published date
05-10-2017
Publisher
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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
ISO 11979-8:2017 specifies 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.
| Committee |
CEN/TC 170
|
| DevelopmentNote |
Supersedes EN 13503-8. (08/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11979-8:2016-04 (Draft) | Identical |
| NBN EN ISO 11979-8 : 2015 | Identical |
| SS-EN ISO 11979-8:2017 | Identical |
| NEN EN ISO 11979-8 : 2017 | Identical |
| DIN EN ISO 11979-8:2017-08 | Identical |
| NF EN ISO 11979-8 : 2017 | Identical |
| NS EN ISO 11979-8 : 2017 | Identical |
| PN EN ISO 11979-8 : 2017 | Identical |
| I.S. EN ISO 11979-8:2017 | Identical |
| ISO 11979-8:2017 | Identical |
| BS EN ISO 11979-8:2017 | Equivalent |
| UNE-EN ISO 11979-8:2017 | Identical |
| BS EN ISO 11979-8:2017 | Identical |
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