BS EN ISO 11979-6:2014
Current
Ophthalmic implants. Intraocular lenses Shelf-life and transport stability testing
Hardcopy , PDF
English
10-31-2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods and sampling
Annex A (informative) - Shelf-life study example
Annex B (informative) - Tests for shelf-life studies
Bibliography
Defines tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined.
| Committee |
CH/172/7
|
| DevelopmentNote |
Supersedes BS EN 13503-6 and 05/30097406 DC. (09/2007) Supersedes 13/30254047 DC. (10/2014)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.
| Standards | Relationship |
| EN ISO 11979-6:2014 | Identical |
| ISO 11979-6:2014 | Identical |
| DIN EN ISO 11979-6:2015-02 | Identical |
| NS EN ISO 11979-6 : 2014 | Identical |
| I.S. EN ISO 11979-6:2014 | Identical |
| NF EN ISO 11979-6 : 2014 | Identical |
| NEN EN ISO 11979-6 : 2014 | Identical |
| NBN EN ISO 11979-6 : 2014 | Identical |
| UNE-EN ISO 11979-6:2015 | Identical |