BS EN ISO 11979-6:2014
Current
The latest, up-to-date edition.
Ophthalmic implants. Intraocular lenses Shelf-life and transport stability testing
Hardcopy , PDF
English
31-10-2014
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 |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ASTM F 1929 : 2015 : REDLINE | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| ISO 2233:2000 | Packaging — Complete, filled transport packages and unit loads — Conditioning for testing |
| ISO/TR 22979:2017 | Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 11979-1:2006 | Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 2248:1985 | Packaging — Complete, filled transport packages — Vertical impact test by dropping |
| ISO 8318:2000 | Packaging — Complete, filled transport packages and unit loads — Sinusoidal vibration tests using a variable frequency |
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